613 Mdr Jobs - Page 12

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Manager - 2 Date: Jun 26, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Key Responsibilities: The candidate is expected to develop LC-MS based methods for protein and peptide product characterization. The candidate is expected to qualify the methods for intended purpose for all pipeline products. The candidate is expected to design and implement integrated strategies, linking appropriate chromatography and mass spectrometry tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on LC-MS, CEX-MS, SEC-MS Characterization of innovator product batches sourced from different geographical region and preparation of quality target profile. Responsible for designing advance workflows such as multi-attribute methods for PTMs, sequence variants, qualitative and quantitative profiling of HCPs, Disulfide shuffling and bond analysis, cell culture metabolite analysis, glycan analysis etc. Preparation and review of method development reports (MDR) and analytical test procedures (ATP). Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations. The candidate is responsible for the operation and maintenance of the MS instruments To manage chemicals,consumables & critical reagents inventory. Performs calibration of instruments and equipment. Troubleshoots instrument performance and equipment issues. Responsible for managing the regulatory queries. The candidate is expected to draft the technical content for regulatory dossier. Educational Qualification: M.SC./M.Tech in Biochemistry / Life Sciences / Biotechnology. Technical/functional Skills: Sound knowledge of analytical method development, qualification and structural and functional characterization of therapeutic proteins. Experience of biosimilarity assessment of biologics for regulated market is desirable. Experience of analytical development for monoclonal antibodies and fusion proteins and peptide is highly desirable. Apply Now » Apply Now Start applying with LinkedIn Please wait...

Great that you're thinking about a career with BSI! Position: Medical devices auditor Location: India(home based) What Duties You'll Perform As a Regulatory Services business stream Client Manager(Auditor) you'll be responsible for frequently travelling and having overnight stays across the South Korea. You'll assess to ISO 13485 quality management systems, EU medical device regulations and MDSAP scheme on customer sites, write up comprehensive reports and present these to the client. You'll also have the opportunity for occasional international travel to the USA and Europe. You'll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation). About BSI And The Regulatory Services Team BSI (British Standards Institution) is the global business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Our Regulatory Services team ensure patient safety while supporting timely market access for our clients Medical Device products globally. BSI has successfully achieved designation as a Notified Body in The Netherlands, is an accredited ISO 13485 Certification Body and is recognized in many global markets. Key Responsibilities & Accountabilities Undertake management system assessments in accordance with BSI requirements. Prepare assessment reports and deliver findings to clients to ensure client understanding of the assessment decision and clear direction to particular items of corrective action where appropriate. Recommend the issue, re-issue or withdrawal of certificates, and report recommendations in accordance with BSI policy, procedures and prescribed time frame. Lead assessment teams as required ensuring that team members are adequately briefed so that quality of service is maintained and that effective working relationships are sustained both with Clients and within the team Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and increased client satisfaction with clients in your portfolio. Provide accurate and prompt information to support services, working closely with them to ensure that client records are up to date and complete and that all other internal information requirements are met. Plan/schedule workloads to make best use of own time and maximise revenue-earning activity. Coach colleagues as appropriate especially where those members are inexperienced assessors or unfamiliar with clients' business/technology and assist in the induction and coaching of new colleagues as requested. Maintain and develop assessment skills and technical and management system standards knowledge. Provide technical support to clients through business development, sales and customer service staff Act as a brand Ambassador for BSI. This means acting ethically, following company rules and promoting BSI services to clients so they are able to optimize business performance and “Make Excellence a Habit”. Candidate specifications Bachelor degree or above with medical device industry related major or main professional qualification in a relevant subject and have a comprehensive knowledge of ISO 13485 and EU medical device regulation * Minimum 5 years quality management and technology management working experience in the fields of Medical devices with biological active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body; Active medical device or active implantable device. IVD devices manufactured using metal or plastic processing, IVD devices manufactured using non-metal mineral processing, (e.g. glass, ceramics, textiles, rubber, leather, paper) Commercial understanding of compliance industry, minimum 2 years quality system management Knowledge of business processes and application of quality management standards Good verbal and written communication skills and an eye for detail Be self motivated, flexible, and have excellent time management/planning skills Can work under pressure Willing to travel on business intensively (80% ) An enthusiastic and committed team player Good public speaking and business development skill will be considered advantageous Key Performance Indicators Delivery of man-days as booked in time and good quality work together with positive feedback from clients Feedback efficiently to both clients and internal queries Timely submission of reports Actively solve problems when needed with “can do” attitude Add value to clients by identifying their needs and introducing multiple BSI services to improve clients business performance and help them “Make excellence a habit” Help to avoid customer attrition by providing quality value added service and technical support Local hire. Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.

At Armor, we are committed to making a meaningful difference in securing cyberspace. Our vision is to be the trusted protector and de facto standard that cloud-centric customers entrust with their risk. We strive to continuously evolve to be the best partner of choice, breaking norms and tirelessly innovating to stay ahead of evolving cyber threats and reshaping how we deliver customer outcomes. We are passionate about making a positive impact in the world, and we’re looking for a highly skilled and experienced talent to join our dynamic team. Armor has unique offerings to the market so customers can a) understand their risk b) leverage Armor to co-manage their risk or c) completely outsource their risk to Armor. Learn more at: https://www.armor.com Summary We are seeking a dedicated Technical Support Engineer L2 to join our cybersecurity Support team. As the first point of contact for our global customers using our Managed Detection and Response (MDR) solutions, you will play a crucial role in ensuring customer satisfaction while maintaining the security and functionality of their systems. Essential Duties and Responsibilities (Additional duties may be assigned as required) Provide technical support to global customers for our MDR platform and related cybersecurity products Monitor systems and network health, generating usage reports and tracking potential security issues Diagnose and troubleshoot basic software problems related to our MDR solutions Manage customer incidents using our ticketing system, ensuring timely resolution according to service level agreements Document incidents, solutions, and maintain accurate records for future reference Assist with basic configuration and deployment of MDR sensors, agents, and monitoring tools Identifying potential problems from Microsoft Sentinel / MS Azure / MS Defender logs Participate in 24x7 support rotation to ensure round-the-clock monitoring and incident response Communicate effectively with customers to understand their needs and provide clear technical guidance Required Skills Bachelor's degree in computer science, Information Technology, Cybersecurity or related field (or equivalent experience) 5+ years of experience in technical support, IT Support role, or cybersecurity operations Rudimentary understanding of intrusion detection, firewall operations, and other general security practices. Create VM templates Add/modify/delete disks through VCD Respond to VMWare host and system alerts Intermediate level of networking expertise with understanding of networking fundamentals and well-known protocols/services including GRE, TCP/IP, V-LAN. Proficiency in Windows Server environments and Linux distributions commonly used in enterprise settings Knowledge of managed detection and response (MDR) technologies is a plus Excellent problem-solving skills and keen ability to diagnose and troubleshoot technical issues. Well-spoken and articulate with an attention to detail with excellent writing abilities. Experience with ticketing systems and ITIL methodologies preferred Ability to work in a fast-paced environment and handle multiple priorities simultaneously Willingness to learn new technologies WHY ARMOR Join Armor if you want to be part of a company that is redefining cybersecurity. Here, you will have the opportunity to shape the future, disrupt the status quo, and be a part of a team that celebrates energy, passion, and fresh thinking. We are not looking for someone who simply fills a role – we want talent who will help us write the next chapter of our growth story. Armor Core Values Commitment to Growth: A growth mindset that encourages continuous learning and improvement with adaptability in the face of challenges. Integrity Always: Sustain trust through transparency + honesty in all actions and interactions regardless of circumstances. Empathy In Action: Active understanding, compassion and support to the needs of others through genuine connection. Immediate Impact: Taking initiative with swift, informed actions to deliver positive outcomes. Follow-Through: Dedication to delivering finished results with attention to quality and detail to achieve the desired outcomes. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually low to moderate. The work environment can be either in an office setting or remotely from anywhere. Equal opportunity employer - it is the policy of the company to comply with all employment laws and to afford equal employment opportunity to individuals in all aspects of employment, including in selection for job opportunities, without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, or any other consideration protected by federal, state or local laws.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Careers that Change Lives Provide Mechanical design quality engineering support in design and development of medical device and non medical products. Facilitate the application of design controls in product development and sustaining changes. Must Have Review new and modified product design documentation for quality characteristics,including manufacturability, serviceability, testability, reliability, and product requirements. Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards. Participate on cross-functional teams to develop product risk management file (risk management plan, Hazard Analysis, DFMEA, and risk management report) as per ISO 14971. Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Review Design History Files and Technical Files for conformance to applicable requirements. Hands-on experience on CAPA support and field complaint analysis. Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques. Assist in creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance. Familiar with statistical software tools (Minitab, Stat Graphics) Participate and provide input to training on department / division procedures and policies. Participate when appropriate in audits Deliver presentations to the QA organization on status and issues of assigned projects. Deliver trainings to departments outside of QA. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Previous experience working in a cross-functional team environment. Minimum Qualification B E or B.Tech in Mechanical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience Additional Competencies Previous experience working in a cross-functional team environment. Good verbal and written communication skills including protocol / report development and technical presentations. Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis. Familiar with DMAIC or DMADV(DFSS) methodologies Nice to Haves ASQ CQE, CQA, CSQE and/or CRE certification. ISO 9001 Internal Auditor / Lead Auditor Certification ISO 13485 Internal Auditor / Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Responsibilities may include the following and other duties may be assigned: Analyze returned products to identify failure modes and root causes. Conduct detailed assessments of device performance, including physical inspection and functional testing. Document investigation findings in the complaint handling system, ensuring accuracy and completeness. Review complaint data for trends and recurring issues. Identify opportunities for streamlining failure analysis workflows to improve efficiency and accuracy. Contribute to the development and implementation of standardized investigation procedures and tools. Support automation initiatives to reduce manual effort in complaint handling Ensure all complaint investigations comply with regulatory requirements (e.g., MDR, FDA). Maintain detailed and accurate records for audits and inspections. Support internal and external audits by providing investigation data and process documentation. Serve as a subject matter expert (SME) for failure analysis techniques and tools. Stay updated on industry standards and best practices for complaint handling and failure analysis. Train and mentor junior team members in complaint investigation and analysis methods. Monitor and report on key performance indicators (KPIs) related to complaint handling (e.g., FTQ, OCT). Drive improvements to meet or exceed quality and timeliness targets. Required knowledge, experience & skills : Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 4 to 8 years of quality systems experience. Strong communication skills, both oral and written. Ability to understand the functionality / intended use of complex medical devices Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis Comfortable working with international and multi-cultural department and groups in different time zones Accurate and delivers quality work, with a sense of urgency. Ability to work well under pressure and maintain positive, enthusiastic attitude. Ability to work in a fast-paced environment .Eagerness to learn and expand responsibilities & accountability . Skills - Nice to have : Knowledge of medical devices, their development and quality control. Knowledge of FDA, MEDDEV, Canadian Regulations. Technical Writing experience. Good interpersonal skills. Ability to work effectively in a team environment and build strong working relationships. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

1. Maintain the QMS documents on the lines of ISO 13485 and GMP 2. Responsible for control of all levels of documents & their history in accordance with EU MDR 3. Coach and Guide the team to support company goals by : Identifying factors that are critical to prospective and retrospective stability studies Participate in the new product registration/ life-cycle management discussions to provide inputs on the procedure for analysis, mainly validations

Company profile : Netenrich boosts the effectiveness of organizations’ security and digital operations so they can avoid disruption and manage risk. Resolution Intelligence CloudTM is our native-cloud data analytics platform for enterprises and services providers that need highly scalable, multitenant security operations and/or digital operations management. Resolution Intelligence Cloud transforms security and operations data into intelligence that organizations can act on before critical issues occur. More than 3,000 customers and managed service providers rely on Netenrich to deliver secure operations at scale. Position: Cybersecurity Enterprise Sales – SIEM Engineering Focus Location: Hyderabad/Bangalore/Mumbai Role Overview: We are seeking a dynamic and results-driven Cybersecurity Enterprise Sales professional to join our team. This role is focused on selling advanced cybersecurity solutions, including SIEM, SOAR , and Adaptive MDR offerings , to mid-to-large enterprises. The ideal candidate will have a strong foundation in cybersecurity operations , particularly SIEM engineering , and a proven track record in enterprise technology sales . Key Responsibilities: · Develop and execute a strategic sales plan to meet and exceed quarterly and annual sales targets. · Identify, qualify, and pursue new business opportunities in enterprise accounts. · Conduct engaging product presentations and solution demonstrations to prospective clients. · Understand customer security needs and map solutions accordingly, with a focus on SIEM, SOAR, and MDR. · Lead contract negotiations and close deals. · Build and maintain long-term relationships with key stakeholders and channel partners. · Stay current on the latest cybersecurity trends and emerging technologies. · Collaborate with internal technical and product teams to align solutions with customer needs. Required Qualifications: · Bachelor's degree in Business, Computer Science, Information Security, or a related field. · Experience in cybersecurity sales , with a focus on enterprise customers . · Hands-on understanding of SIEM tools (e.g., Splunk, IBM QRadar, Securonix) and security operations workflows . · Proven ability to meet or exceed sales targets in a complex, solution-oriented environment. · Excellent communication, presentation, and negotiation skills. · Self-starter with the ability to work independently and cross-functionally. Preferred Skills: · Experience selling MDR, SIEM, SOAR , or AI-driven security solutions . · Familiarity with SaaS security platforms and cloud security posture management . · Background in threat detection, incident response , or SIEM engineering is a strong plus. Share your updated profile at naveen.vemula@netenrich.com

Company Overview RegTrac is a leading healthcare regulatory partner specializing in Global Regulatory Affairs, Quality Systems, and Compliance for Medical Devices, Cosmetics, and Consumer Products. With expertise in navigating regulatory requirements across diverse markets, RegTrac empowers MedTech companies to innovate and expand globally while ensuring regulatory compliance. Our comprehensive services include strategic insights, compliance mastery, and training programs in Regulatory Affairs to support businesses in achieving success. Role Description: We are seeking a highly motivated Senior Regulatory Affairs Associate who will lead and support regulatory projects across global markets, with a focus on Clinical Documentation – Clinical Evaluation & Investigations for CE/UKCA, EU MDR compliance, and medical device documentation. In this role, you will be managing client relationships, preparing regulatory submissions, and ensuring adherence to ISO and QMS standards. You will collaborate cross-functionally, support audits, and contribute to solution development for new business. Ideal for a proactive, detail-oriented professional seeking to grow in a dynamic regulatory consulting environment. Key Responsibilities: Regulatory Affairs: · Regulatory experience in preparing CER/CEP, technical files and supporting projects for CE/ UKCA in Europe. · EUMDR experience providing support for the clients and leading client projects. · Good knowledge of medical device labelling and understanding of review & approvals for medical device labels. · Good knowledge of ISO standards / Industry compliance regulatory standards like ISO 13485/ 10993/ 14971. · Support & resolve regulatory document related queries from manufacturers and provide solutions. · Provide support for sales and solutioning in completing requirement analysis for leads in winning projects. · Ensure client projects are performed and documentation prepared, reviewed and approved in line with relevant legislation requirements and guidance, meeting any specific requests or methodologies following the system and procedures in place. · Manage and build on client relationship’s ensuring feedback sessions are completed on a regular basis. · Be up to date with changing regulatory requirements and guidelines and update the company with these changes. · Prepare solutions, proposals and estimate the required effort hours in support of sales team including supporting sales presentations. · Ability to manage projects, teams and work cross-departmentally to gather project-specific requirements, information, and needs. · Foster a dynamic working relationship with RegTrac Clients. RA-QMS: · Author review and approved relevant procedures as applicable as per the required QMS system. · Monitor Quality processes and procedures required to ensure the applicable standard is achieved, including approved QMS. · Provide internal stakeholders a guidance and recommendations in the application of all relevant Industry Standards and Regulations. · Monitor customer/supplier quality and provide rapid response for quality problems from regulatory requirements. · Provide support to oversee all Audits, external and internal inspections, and their reporting, ensuring compliance and conduct supplier/customer audits where required in collaboration with QA team. Qualifications: · Advanced degree (Master’s or PhD) in a relevant field. · 5 years of experience in Quality, Regulatory affairs or governance in a structured environment. · Have excellent written and oral communications skills to communicate clearly and effectively with third parties, regulatory authorities and management. · Inquisitive, self-motivated and focused. · Self-Starter, Keen to learn, Ability to plan, good organisational skills and work in a team. · Proven strengths in attention to detail, analytical ability, understanding and interpreting regulations. · Looking for a company where they may broaden their experience and grow with the company. · You will be process driven with a can-do approach to find fitting and effective solutions to move projects forward. Why Join RegTrac? At RegTrac , you'll join a collaborative, supportive team that values expertise, curiosity, and purpose. The company fosters a culture of continuous learning, where your voice matters and your growth is actively supported through mentorship, diverse global projects, and real responsibility. You’ll be part of a close-knit community passionate about regulatory science and improving healthcare outcomes, with the flexibility to work remotely and balance life outside of work. At RegTrac, it’s not just about compliance—it’s about making a meaningful impact together, in a place where people genuinely enjoy what they do and who they do it with.

Senior Regulatory Affairs Manager The Senior Regulatory Affairs Manager will be responsible for supporting international regulatory affairs registrations of medical devices across the globe. Job Description This position involves the creation, identification, collection, and entry of regulatory affairs information related to medical devices. The role includes supporting international regulatory submissions, managing country registration requests, and ensuring compliance with global regulatory requirements. The position requires strong organizational skills, effective communication, and the ability to manage multiple tasks efficiently . Essential Responsibilities Create, submit, and maintain product registration requests for submission. Develop, submit, and manage EU MDR, MDSAP, and EN ISO 13485 documents for regulatory compliance. Review and approve submission documents to ensure compliance with regulatory standards. Maintain up-to-date metrics with product registration requests and submission schedules. Track and monitor regulations applicable to medical devices in designated countries. Manage and update internal regulatory databases, including licenses and registration records . Qualifications Educational Background B.S. degree or higher in a technical discipline, preferably in Computer Science, Engineering, Bioengineering, Biology, or Chemistry . Professional Experience 3-7 years of Regulatory Affairs experience in the medical device industry , including international product registrations and new product development. Knowledge and Skills Knowledge: Working knowledge of 510(k) submissions, EU MDR 2017/745, MDSAP, EN ISO 13485, and 21 CFR 820 - Quality System. Skills: Proficient in Microsoft Word, Excel, and PowerPoint. Strong communication skills (oral and written) in English. Excellent project management skills. Ability to manage multiple tasks with strong attention to detail. Self-motivated and comfortable working remotely with international teams. Organized and analytical thinker with problem-solving abilities.  Primary Work Location: Valsad, Gujarat

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Radiometer, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We’re a team that celebrates diverse ideas and continuous improvement. Here, you’ll find a place to grow and make a real impact, with your unique perspective driving us forward in improving patient care. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. Learn about the Danaher Business System which makes everything possible. The RA Specialist at Radiometer IDC ensures regulatory compliance and market access for medical devices and IVD products in South Asia. Key responsibilities include managing registrations, preparing and submitting product dossiers, and working with local authorities, agents, and distributors to secure timely approvals This position reports to the Associate Manager, RA and is part of the Regulatory Affairs department located in Bengaluru, India and will be an on-site role. If you thrive in a fast-paced environment, is used to playing a critical supporting and coordinating role and want to work to build a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale—read on. In this role, you will have the opportunity to: As part of licensing and registration procedures for our products (medical devices and IVD) your main tasks include: Lead and manage product registration activities across South Asian countries by ensuring compliance with country-specific regulatory requirements, while monitoring regulatory status, submission timelines, and post-market requirements in the region. Prepare, compile, and review regulatory dossiers, applications, and technical documentation for Radiometer medical devices, IVDs and software products. Collaborate with regulatory consultants, distributors, and health authorities to facilitate smooth submissions and responses. Track and analyze local regulatory changes, maintain registration databases, and ensure compliance of labeling, packaging, and promotional materials with local requirements, while providing internal updates and supporting audits Collaborate with Product Regulatory, Quality, Supply Chain, and Commercial teams to support market entry strategies, ongoing compliance, and product lifecycle management activities including handling registrations for countries like Canada and the EU. The essential requirements of the job include: Bachelor’s or master’s degree in life science, Engineering, Pharmacy, Biology, Biochemistry related filed Over 10 years of regulatory affairs experience in the medical device, IVD, or pharmaceutical industry, with specific expertise in South Asian markets, including knowledge of CDSCO, Import License Class A–D (India), DGDA (Bangladesh), NMRA (Sri Lanka), and Health Canada regulations. Skilled in managing multiple projects independently, coordinating with diverse stakeholders, and applying ISO 13485 and ISO 14971 standards, with familiarity in EU MDR, IVDR, and FDA frameworks. Proficiency in preparing and submitting technical files, registration dossiers, and XML-based submissions, with advanced knowledge of MS Office and Adobe Acrobat. Experience working with distributors in South Asia, providing regulatory guidance and support. Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role Ability to travel – list specifics % travel, overnight, within territory or locations Must have a valid driver’s license with an acceptable driving record Ability to lift, move or carry equipment up to ##lb, any other physical requirements It would be a plus if you also possess previous experience in: Experience with regulatory submissions, including FDA 510(k) and EU MDR/IVDR Technical Files. Involvement in pre-market or post-market audits by CDSCO or Notified Bodies. Proficient in UDI, GUDID, and conducting international regulatory assessments for medical device design changes. Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com. At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

About Us Sophos is a global leader and innovator of advanced security solutions for defeating cyberattacks. The company acquired Secureworks in February 2025, bringing together two pioneers that have redefined the cybersecurity industry with their innovative, native AI-optimized services, technologies and products. Sophos is now the largest pure-play Managed Detection and Response (MDR) provider, supporting more than 28,000 organizations. In addition to MDR and other services, Sophos’ complete portfolio includes industry-leading endpoint, network, email, and cloud security that interoperate and adapt to defend through the Sophos Central platform. Secureworks provides the innovative, market-leading Taegis XDR/MDR, identity threat detection and response (ITDR), next-gen SIEM capabilities, managed risk, and a comprehensive set of advisory services. Sophos sells all these solutions through reseller partners, Managed Service Providers (MSPs) and Managed Security Service Providers (MSSPs) worldwide, defending more than 600,000 organizations worldwide from phishing, ransomware, data theft, other every day and state-sponsored cybercrimes. The solutions are powered by historical and real-time threat intelligence from Sophos X-Ops and the newly added Counter Threat Unit (CTU). Sophos is headquartered in Oxford, U.K. More information is available at www.sophos.com. Role Summary MDR Sales Lead is an overlay Sales function. The person would be a second layer of specialised engagement with the existing Enterprise customers, prospects and is expected to have an in-depth understanding of the managed security services and market opportunity available. Person should be able to position the MDR services effectively and appropriately with the customers and build the business opportunity for Sophos India working closely with all the stakeholders across the Globe. What you will do As the Sales Leader for MDR Services, you would be the lead for Services Sales for the country. You will be a part of defining the strategy for MDR Services growth in India, strengthen key relationships with C-level executives, build visibility for and expand business for Sophos India‚ MDR Services. You will work closely with Regional Heads and Sales Leaders for the Account/partner management teams, Presales and Solution Leaders and drive the right engagement with customers to showcase the strength of the Sophos MDR services You will also partner with other functional teams across Product, Compliance, Operations and Enablement to remove barriers and ensure flawless execution and success of the customer engagement. The ideal candidate will possess Sales and Technical knowledge with exposure to sales and delivery of Security Services that enables him or her to develop and execute the plan, to meet Order and Revenue objectives. The person is also expected to be a self-starter who will elevate the conversation with customers to strategic levels and build long standing relationships for Sophos India Develop and execute the plan to meet and exceed book of orders & Revenue targets Effectively position Sophos MDR Services You should possess excellent inter-personal skills to seamlessly collaborate with the entire Sales team Manage all the moving parts of the business with the relevant stakeholders Opportunity ownership and qualification / creation of funnel, forecast deal closures Provide Market insights and competition updates to stakeholders Maintain operational discipline in all execution parameters; respond to all weekly, monthly, quarterly updates in time as may be expected on an on-going basis Support Sales team effectively through regular conversations and support them in handling their respective customer patches effectively to enable them to meet their targets and objectives Handle training activities with the sales teams as may be required What you will bring Min 5-10 years of Cyber security industry experience with minimum 5 years in security services selling Any Security certifications will be an advantage, but not a must Must show demonstrable experience in having developed C-level relationships Demonstrate business acumen in presenting solutions on an ROI basis, strategies, successful penetration of territories for services business growth and across an entire spectrum of buyers, influencers and C-Level decision makers Relationship with Enterprise level of customer, >5000 users Prior CRM experience (preferable Salesforce) #B2 Ready to Join Us? At Sophos, we believe in the power of diverse perspectives to fuel innovation. Research shows that candidates sometimes hesitate to apply if they don't check every box in a job description. We challenge that notion. Your unique experiences and skills might be exactly what we need to enhance our team. Don't let a checklist hold you back – we encourage you to apply. What's Great About Sophos? · Sophos operates a remote-first working model, making remote work the primary option for most employees. However, some roles may necessitate a hybrid approach. Please refer to the location details in our job postings for further information. · Our people – we innovate and create, all of which are accompanied by a great sense of fun and team spirit · Employee-led diversity and inclusion networks that build community and provide education and advocacy · Annual charity and fundraising initiatives and volunteer days for employees to support local communities · Global employee sustainability initiatives to reduce our environmental footprint · Global fitness and trivia competitions to keep our bodies and minds sharp · Global wellbeing days for employees to relax and recharge · Monthly wellbeing webinars and training to support employee health and wellbeing Our Commitment To You We’re proud of the diverse and inclusive environment we have at Sophos, and we’re committed to ensuring equality of opportunity. We believe that diversity, combined with excellence, builds a better Sophos, so we encourage applicants who can contribute to the diversity of our team. All applicants will be treated in a fair and equal manner and in accordance with the law regardless of gender, sex, gender reassignment, marital status, race, religion or belief, color, age, military veteran status, disability, pregnancy, maternity or sexual orientation. We want to give you every opportunity to show us your best self, so if there are any adjustments we could make to the recruitment and selection process to support you, please let us know. Data Protection If you choose to explore an opportunity, and subsequently share your CV or other personal details with Sophos, these details will be held by Sophos for 12 months in accordance with our Privacy Policy and used by our recruitment team to contact you regarding this or other relevant opportunities at Sophos. If you would like Sophos to delete or update your details at any time, please follow the steps set out in the Privacy Policy describing your individual rights. For more information on Sophos’ data protection practices, please consult our Privacy Policy Cybersecurity as a Service Delivered | Sophos

About Us Sophos is a global leader and innovator of advanced security solutions for defeating cyberattacks. The company acquired Secureworks in February 2025, bringing together two pioneers that have redefined the cybersecurity industry with their innovative, native AI-optimized services, technologies and products. Sophos is now the largest pure-play Managed Detection and Response (MDR) provider, supporting more than 28,000 organizations. In addition to MDR and other services, Sophos’ complete portfolio includes industry-leading endpoint, network, email, and cloud security that interoperate and adapt to defend through the Sophos Central platform. Secureworks provides the innovative, market-leading Taegis XDR/MDR, identity threat detection and response (ITDR), next-gen SIEM capabilities, managed risk, and a comprehensive set of advisory services. Sophos sells all these solutions through reseller partners, Managed Service Providers (MSPs) and Managed Security Service Providers (MSSPs) worldwide, defending more than 600,000 organizations worldwide from phishing, ransomware, data theft, other every day and state-sponsored cybercrimes. The solutions are powered by historical and real-time threat intelligence from Sophos X-Ops and the newly added Counter Threat Unit (CTU). Sophos is headquartered in Oxford, U.K. More information is available at www.sophos.com. Role Summary MDR Sales Lead is an overlay Sales function. The person would be a second layer of specialised engagement with the existing Enterprise customers, prospects and is expected to have an in-depth understanding of the managed security services and market opportunity available. Person should be able to position the MDR services effectively and appropriately with the customers and build the business opportunity for Sophos India working closely with all the stakeholders across the Globe. What you will do As the Sales Leader for MDR Services, you would be the lead for Services Sales for the country. You will be a part of defining the strategy for MDR Services growth in India, strengthen key relationships with C-level executives, build visibility for and expand business for Sophos India‚ MDR Services. You will work closely with Regional Heads and Sales Leaders for the Account/partner management teams, Presales and Solution Leaders and drive the right engagement with customers to showcase the strength of the Sophos MDR services You will also partner with other functional teams across Product, Compliance, Operations and Enablement to remove barriers and ensure flawless execution and success of the customer engagement. The ideal candidate will possess Sales and Technical knowledge with exposure to sales and delivery of Security Services that enables him or her to develop and execute the plan, to meet Order and Revenue objectives. The person is also expected to be a self-starter who will elevate the conversation with customers to strategic levels and build long standing relationships for Sophos India Develop and execute the plan to meet and exceed book of orders & Revenue targets Effectively position Sophos MDR Services You should possess excellent inter-personal skills to seamlessly collaborate with the entire Sales team Manage all the moving parts of the business with the relevant stakeholders Opportunity ownership and qualification / creation of funnel, forecast deal closures Provide Market insights and competition updates to stakeholders Maintain operational discipline in all execution parameters; respond to all weekly, monthly, quarterly updates in time as may be expected on an on-going basis Support Sales team effectively through regular conversations and support them in handling their respective customer patches effectively to enable them to meet their targets and objectives Handle training activities with the sales teams as may be required What you will bring Min 5-10 years of Cyber security industry experience with minimum 5 years in security services selling Any Security certifications will be an advantage, but not a must Must show demonstrable experience in having developed C-level relationships Demonstrate business acumen in presenting solutions on an ROI basis, strategies, successful penetration of territories for services business growth and across an entire spectrum of buyers, influencers and C-Level decision makers Relationship with Enterprise level of customer, >5000 users Prior CRM experience (preferable Salesforce) #B2 Ready to Join Us? At Sophos, we believe in the power of diverse perspectives to fuel innovation. Research shows that candidates sometimes hesitate to apply if they don't check every box in a job description. We challenge that notion. Your unique experiences and skills might be exactly what we need to enhance our team. Don't let a checklist hold you back – we encourage you to apply. What's Great About Sophos? · Sophos operates a remote-first working model, making remote work the primary option for most employees. However, some roles may necessitate a hybrid approach. Please refer to the location details in our job postings for further information. · Our people – we innovate and create, all of which are accompanied by a great sense of fun and team spirit · Employee-led diversity and inclusion networks that build community and provide education and advocacy · Annual charity and fundraising initiatives and volunteer days for employees to support local communities · Global employee sustainability initiatives to reduce our environmental footprint · Global fitness and trivia competitions to keep our bodies and minds sharp · Global wellbeing days for employees to relax and recharge · Monthly wellbeing webinars and training to support employee health and wellbeing Our Commitment To You We’re proud of the diverse and inclusive environment we have at Sophos, and we’re committed to ensuring equality of opportunity. We believe that diversity, combined with excellence, builds a better Sophos, so we encourage applicants who can contribute to the diversity of our team. All applicants will be treated in a fair and equal manner and in accordance with the law regardless of gender, sex, gender reassignment, marital status, race, religion or belief, color, age, military veteran status, disability, pregnancy, maternity or sexual orientation. We want to give you every opportunity to show us your best self, so if there are any adjustments we could make to the recruitment and selection process to support you, please let us know. Data Protection If you choose to explore an opportunity, and subsequently share your CV or other personal details with Sophos, these details will be held by Sophos for 12 months in accordance with our Privacy Policy and used by our recruitment team to contact you regarding this or other relevant opportunities at Sophos. If you would like Sophos to delete or update your details at any time, please follow the steps set out in the Privacy Policy describing your individual rights. For more information on Sophos’ data protection practices, please consult our Privacy Policy Cybersecurity as a Service Delivered | Sophos

About Us Sophos is a global leader and innovator of advanced security solutions for defeating cyberattacks. The company acquired Secureworks in February 2025, bringing together two pioneers that have redefined the cybersecurity industry with their innovative, native AI-optimized services, technologies and products. Sophos is now the largest pure-play Managed Detection and Response (MDR) provider, supporting more than 28,000 organizations. In addition to MDR and other services, Sophos’ complete portfolio includes industry-leading endpoint, network, email, and cloud security that interoperate and adapt to defend through the Sophos Central platform. Secureworks provides the innovative, market-leading Taegis XDR/MDR, identity threat detection and response (ITDR), next-gen SIEM capabilities, managed risk, and a comprehensive set of advisory services. Sophos sells all these solutions through reseller partners, Managed Service Providers (MSPs) and Managed Security Service Providers (MSSPs) worldwide, defending more than 600,000 organizations worldwide from phishing, ransomware, data theft, other every day and state-sponsored cybercrimes. The solutions are powered by historical and real-time threat intelligence from Sophos X-Ops and the newly added Counter Threat Unit (CTU). Sophos is headquartered in Oxford, U.K. More information is available at www.sophos.com. Role Summary MDR Sales Lead is an overlay Sales function. The person would be a second layer of specialised engagement with the existing Enterprise customers, prospects and is expected to have an in-depth understanding of the managed security services and market opportunity available. Person should be able to position the MDR services effectively and appropriately with the customers and build the business opportunity for Sophos India working closely with all the stakeholders across the Globe. What you will do As the Sales Leader for MDR Services, you would be the lead for Services Sales for the country. You will be a part of defining the strategy for MDR Services growth in India, strengthen key relationships with C-level executives, build visibility for and expand business for Sophos India‚ MDR Services. You will work closely with Regional Heads and Sales Leaders for the Account/partner management teams, Presales and Solution Leaders and drive the right engagement with customers to showcase the strength of the Sophos MDR services You will also partner with other functional teams across Product, Compliance, Operations and Enablement to remove barriers and ensure flawless execution and success of the customer engagement. The ideal candidate will possess Sales and Technical knowledge with exposure to sales and delivery of Security Services that enables him or her to develop and execute the plan, to meet Order and Revenue objectives. The person is also expected to be a self-starter who will elevate the conversation with customers to strategic levels and build long standing relationships for Sophos India Develop and execute the plan to meet and exceed book of orders & Revenue targets Effectively position Sophos MDR Services You should possess excellent inter-personal skills to seamlessly collaborate with the entire Sales team Manage all the moving parts of the business with the relevant stakeholders Opportunity ownership and qualification / creation of funnel, forecast deal closures Provide Market insights and competition updates to stakeholders Maintain operational discipline in all execution parameters; respond to all weekly, monthly, quarterly updates in time as may be expected on an on-going basis Support Sales team effectively through regular conversations and support them in handling their respective customer patches effectively to enable them to meet their targets and objectives Handle training activities with the sales teams as may be required What you will bring Min 5-10 years of Cyber security industry experience with minimum 5 years in security services selling Any Security certifications will be an advantage, but not a must Must show demonstrable experience in having developed C-level relationships Demonstrate business acumen in presenting solutions on an ROI basis, strategies, successful penetration of territories for services business growth and across an entire spectrum of buyers, influencers and C-Level decision makers Relationship with Enterprise level of customer, >5000 users Prior CRM experience (preferable Salesforce) #B2 Ready to Join Us? At Sophos, we believe in the power of diverse perspectives to fuel innovation. Research shows that candidates sometimes hesitate to apply if they don't check every box in a job description. We challenge that notion. Your unique experiences and skills might be exactly what we need to enhance our team. Don't let a checklist hold you back – we encourage you to apply. What's Great About Sophos? · Sophos operates a remote-first working model, making remote work the primary option for most employees. However, some roles may necessitate a hybrid approach. Please refer to the location details in our job postings for further information. · Our people – we innovate and create, all of which are accompanied by a great sense of fun and team spirit · Employee-led diversity and inclusion networks that build community and provide education and advocacy · Annual charity and fundraising initiatives and volunteer days for employees to support local communities · Global employee sustainability initiatives to reduce our environmental footprint · Global fitness and trivia competitions to keep our bodies and minds sharp · Global wellbeing days for employees to relax and recharge · Monthly wellbeing webinars and training to support employee health and wellbeing Our Commitment To You We’re proud of the diverse and inclusive environment we have at Sophos, and we’re committed to ensuring equality of opportunity. We believe that diversity, combined with excellence, builds a better Sophos, so we encourage applicants who can contribute to the diversity of our team. All applicants will be treated in a fair and equal manner and in accordance with the law regardless of gender, sex, gender reassignment, marital status, race, religion or belief, color, age, military veteran status, disability, pregnancy, maternity or sexual orientation. We want to give you every opportunity to show us your best self, so if there are any adjustments we could make to the recruitment and selection process to support you, please let us know. Data Protection If you choose to explore an opportunity, and subsequently share your CV or other personal details with Sophos, these details will be held by Sophos for 12 months in accordance with our Privacy Policy and used by our recruitment team to contact you regarding this or other relevant opportunities at Sophos. If you would like Sophos to delete or update your details at any time, please follow the steps set out in the Privacy Policy describing your individual rights. For more information on Sophos’ data protection practices, please consult our Privacy Policy Cybersecurity as a Service Delivered | Sophos

The Senior Developer will be responsible for mdr,medical iso13485 process and Process Failure Mode Effect Analysis (PFMEA). The primary objective is to develop and implement software solutions in compliance with medical device regulations and quality standards. (1.) Key Responsibilities 1. Develop and maintain software applications in adherence to mdr,medical iso13485 process requirements 2. Conduct process failure mode effect analysis (pfmea) to identify and mitigate risks in software development processes 3. Collaborate within team to ensure software solutions meet regulatory standards and quality expectations 4. Participate in audits and reviews to assess software development processes for compliance with industry regulations 5. Provide technical expertise and guidance on mdr,medical iso13485 process and pfmea best practices Skill Requirements 1. Proficiency in mdr,medical iso13485 process and quality management systems 2. Experience in conducting process failure mode effect analysis (pfmea) in software development projects 3. Strong knowledge of medical device regulations and standards 4. Good problem-solving skills and attention to detail 5. Ability to work effectively in a team environment and communicate complex technical concepts clearly 6. Familiarity with software development lifecycle and best practices Certifications: Certification in mdr,medical iso13485 process or PFMEA is a plus No. of Positions 3 Skill (Primary) Technical Skills (ERS)-SAP PLM - Configuration-Process Failure Mode Effect Analy(PFMEA) Auto req ID 1569124BR Skill Level 3 (Secondary Skill 1) Tools and Standards (ERS)-Standards - Medical-MDR Skill Level 3 (Secondary Skill 2) Tools and Standards (ERS)-HW Product Dev Process Standard-Medical - ISO13485 Process

Summary The Security Engineer GSOC is responsible for all aspects of onboarding and troubleshooting for SentinelOne and AlienVault for all MDR engagements. The Security Engineer GSOC provides onboarding support, SentinelOne agent installation, troubleshooting the issues if any, sensor deployments in AlienVault and deployment of other components in SIEM solutions, log source onboarding in SIEM, and related activities for all active engagements. The Security Engineer GSOC supports overall implementation by providing necessary support for current matters. The Security Engineer GSOC role takes direction on what is needed regarding all aspects of SentinelOne and AlienVault for the engagements. The Security Engineer GSOC works with the MDR team to support SentinelOne installations, interoperability issues, exclusions, whitelisting, and overall troubleshooting. The Security Engineer GSOC ensures that SentinelOne is deployed to a client’s environment they are fully protected by it and clients opting for SIEM solutions are aptly covered from security standpoint. Roles & Responsibilities Communicates with the client to initiate the onboarding. Prepares and shares the network prerequisites and SentinelOne packages Ensures all required details are in place before an activity is started Handles all SentinelOne-related inquiries and tasks for their assigned projects Documents SOP and procedures related to common client inquiries related to SentinelOne deployment, support, and troubleshooting Provides resolution for onboarding/performance-related issues to MDR team or engages directly with the client with guidance Provides daily reports on SentinelOne deployment status Provides technical training and acclimation for clients to familiarize themselves with the S1 interface and functionalities Drives all AlienVault deployments with customers Understands the architecture, deploys the sensors, and prepares the log baseline for assets in scope for log collection Ensures ingested logs are parsed properly and alarms are getting triggered as expected Develops custom parsers for applications to onboard them to SIEM solutions May perform other duties as assigned by management Skills And Knowledge Working understanding of API queries Working understanding of scripting Working understanding of developing PowerShell scripts and writing batch files for ad hoc requirements General understanding of Windows and Unix Intervals Working understanding of information security. Thorough understanding of analysis techniques for reviewing large datasets Working understanding of TCP/IP and OSI Model Thorough understanding of the Incident Response Life Cycle (Preparation, Identification, Containment, Eradication, Recovery, Lesson Learned) Working understanding of the MITRE ATT&CK framework Ability to communicate in both technical and non-technical terms both oral and written General understanding of: Network Security Monitoring (NSM), network traffic analysis, and log analysis Penetration Testing / Vulnerability Scanning Thorough understanding of enterprise security controls in Active Directory / Windows environments Experience with hands-on penetration testing against Windows, Unix, or web application targets Job Requirements Associate's degree and 6-8 years of IT security-related experience or Bachelor's degree and 2-5 years related experience Current or previous experience with Endpoint Detection and Response (EDR) toolsets SOC/CIRT team experience Applied knowledge in at least one scripting or development language (such as Python), preferred DISCLAIMER The above statements are intended to describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all responsibilities, duties and skills required personnel so classified. WORK ENVIRONMENT While performing the responsibilities of this position, the work environment characteristics listed below are representative of the environment the employee will encounter: Usual office working conditions. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of this job. PHYSICAL DEMANDS No physical exertion required Travel within or outside of the state Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force as frequently as needed to move objects TERMS OF EMPLOYMENT Salary and benefits shall be paid consistent with Arete salary and benefit policy. FLSA OVERTIME CATEGORY Job is exempt from the overtime provisions of the Fair Labor Standards Act. DECLARATION The Arete Incident Response Human Resources Department retains the sole right and discretion to make changes to this job description. EQUAL EMPLOYMENT OPPORTUNITY We’re proud to be an equal opportunity employer- and celebrate our employees’ differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Different makes us better. Arete Incident Response is an outstanding (and growing) company with a very dedicated, fun team. We offer competitive salaries, fully paid benefits including Medical/Dental, Life/Disability Insurance, 401(k) and the opportunity to work with some of the latest and greatest in the fast-growing cyber security industry. When you join Arete… You’ll be doing work that matters alongside other talented people, transforming the way people, businesses, and things connect with each other. Of course, we will offer you great pay and benefits, but we’re about more than that. Arete is a place where you can craft your own path to greatness. Whether you think in code, words, pictures or numbers, find your future at Arete, where experience matters. Equal Employment Opportunity We’re proud to be an equal opportunity employer- and celebrate our employees’ differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Different makes us better.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Careers that Change Lives Provide Mechanical design quality engineering support in design and development of medical device and non medical products. Facilitate the application of design controls in product development and sustaining changes. Must Have Review new and modified product design documentation for quality characteristics,including manufacturability, serviceability, testability, reliability, and product requirements. Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards. Participate on cross-functional teams to develop product risk management file (risk management plan, Hazard Analysis, DFMEA, and risk management report) as per ISO 14971. Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards. Review Design History Files and Technical Files for conformance to applicable requirements. Hands-on experience on CAPA support and field complaint analysis. Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques. Assist in creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance. Familiar with statistical software tools (Minitab, Stat Graphics) Participate and provide input to training on department / division procedures and policies. Participate when appropriate in audits Deliver presentations to the QA organization on status and issues of assigned projects. Deliver trainings to departments outside of QA. Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator. Previous experience working in a cross-functional team environment. Minimum Qualification B E or B.Tech in Mechanical Engineering Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience Additional Competencies Previous experience working in a cross-functional team environment. Good verbal and written communication skills including protocol / report development and technical presentations. Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis. Familiar with DMAIC or DMADV(DFSS) methodologies Nice to Haves ASQ CQE, CQA, CSQE and/or CRE certification. ISO 9001 Internal Auditor / Lead Auditor Certification ISO 13485 Internal Auditor / Lead Auditor Certification Lean Six Sigma Green Belt or Black Belt Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

Job Title Senior Regulatory Affairs Manager Job Description Job Description: In this role, you will lead a Regulatory Affairs Team for our Magnetic Resonance Imaging (MRI) Business Unit, Bangalore & Pune. You will also be accountable for developing and deploying innovative, compliant regulatory strategies to grow and sustain the MRI portfolio. This portfolio spans imaging medical systems and software and drives Philips’ mission to improve the lives of 2.5 billion people by 2030. This position requires building and strengthening regulatory capabilities to drive, but not be limited to, software and AI applications and bring efficiencies through excellence in regulatory operations. This position reports to the Director-Regulatory Affairs, MRI Business Unit. Your role: Lead Regulatory Affairs team, from end to end (product inception through to lifecycle management), driving innovation, actively providing value-added regulatory affairs input and deliverables for new product introductions and product changes across the globe. Led the development and deployment of innovative Regulatory strategies with efficiency and compliance, bringing products to market and maintaining them compliantly to support business growth. This position will develop and execute the regulatory strategy for new product development, design changes and field safety corrections for US, EU and RoW. Author and lead 510(k) submissions, pre-sub meetings, EU MDR Technical Documentation, and Health Canada license applications. Lead interactions with regulators/competent authorities throughout the review and approval process. Participate in strategic product development, design solutions from the concept phase to the product delivery phase and provide regulatory guidance throughout design and development. Act as a Regulatory Subject Matter Expert on various aspects and provide strategic guidance to the other RA Staff and project team. Able to manage special projects across the spectrum of product lines. Responsible for monitoring global regulatory landscapes and guiding cross-functional teams in implementing regulation changes. Communicate new and upcoming changes and facilitate/assist with interpretation to guide product and business compliance with Regulatory requirements. Review labelling, marketing materials, and claims substantiation evidence to maintain compliance with global requirements. Identify areas for improvement in efficiency and compliance in internal processes, work instructions, and forms and apply technical expertise to process improvement efforts. Lead or participate in process improvement teams to affect local or cross-business unit changes. Opportunity for mentoring and coaching other regulatory team members and provide regulatory guidance. Responsible for the hiring and developing critical talent within the Global Regulatory Affairs Team through creating and sustaining robust career & development plans, ongoing coaching and feedback, and identifying and addressing gaps in capabilities and competencies. Led and enabled strong cross-functional partnerships between Regulatory Affairs and all key stakeholders, including R&D, Marketing, Quality, Clinical Affairs and other functions at all levels within the Business Unit. Building proactive, robust, strategic relationships with external stakeholders (FDA, NBs, CAs, MedTech forums, etc.) to influence and shape the external regulatory landscape across the domains relevant to the innovation agenda Providing critical input on regulatory risk assessments to support portfolio selection. You're the right fit if you have the following: A preferred candidate with a master's degree in engineering or a related field and a minimum of 10-12 years of experience in Regulatory Affairs in the medical device industry, with regulatory submission like 510(k), EU MDR Technical documentation and global registration experience, is a must. (Experience with SaMD, AI, and digital health is a significant advantage.) Extensive experience and knowledge required of global medical device regulations, requirements, and standards 10 years of experience in people management – with a strong track record in successfully leading a Regulatory Affairs team Proven track record of leading in a matrix organization, leading cross-functional and diverse teams with challenging goals Experience with successful preparation and submission of Design Dossiers, 510(k), PMA, Technical /Design Dossiers and international documents or registration of medical devices worldwide. Strong written, oral, and interpersonal skills required to lead a team as well as individual contributor. Solution- and detail-oriented, well-organized, self-motivated, and has the ability to negotiate with regulators. It may require up to 10% travel internationally per business needs. How We Work Together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Indicate if this role is an office/field/onsite role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Join Our Team at Zenith Quality Assessors Pvt. Ltd., Pune, Maharashtra, India Zenith Quality Assessors Pvt. Ltd., Vimannagar, Pune is registered as an “Indian Notified Body” for Indian Medical Device Rule (MDR) 2017 under Central Drugs Standard Control Organization (CDSCO). We are also an Internationally Accredited Third Party Audit and Certification Body providing Management Systems certifications for different Standards / Schemes (ISO 9001, ISO 13485, ICMED 13485, ICMED 13485 Plus, etc.). Additionally, Zenith provides audit and certification services for CE Conformity Assessments in co-operation with Internationally recognized EU Notified Bodies & Product Certification Bodies. To know more about us, please visit www.zenith-worldwide.com Position Available : ISO 9001 QMS Lead Auditor Qualification : Bachelors / Masters Degree in Engineering (Mechanical, Electrical, Electronics) Work Experience : Minimum 2 years and Maximum 4 years in Engineering Industry (i.e. Manufacturing, QA/QC, Regulatory Affairs Departments). Pre-requisite : ISO 9001 Quality Management System Lead Auditor Certificate. Second Party / Third Party Audit Experience preferred Location : Pune If interested, please write to us with your updated Resume at certification@zenith-worldwide.com alongwith Current/Expected CTC. If not relevant to you, will appreciate if you could further share this opportunity to any eligible candidate of your reference

About the Role We are seeking an experienced Enterprise Solutions Architect with deep expertise in MedTech product engineering, connected device ecosystems, patient data management, and health cloud platforms . This role will be instrumental in supporting our global solutioning team by driving deal support, POV creation, solution frameworks, and strategic innovation for our connected care and digital MedTech clients . What You Will Do Lead the design and development of end-to-end digital MedTech solutions , especially in areas like device connectivity, remote diagnostics, post-market surveillance, and patient data platforms. Convert business requirements and client pain points into technical solution blueprints and proposal responses across RFPs, RFIs, and proactive pitches. Architect and evaluate technical stacks using IoMT protocols (Bluetooth LE, Zigbee, LoRa, NB-IoT), FHIR/HL7 standards , and Health Cloud offerings (AWS HealthLake, Azure Health Data Services). Collaborate with platform and device engineering teams to define interoperable and secure architecture across software and embedded systems . Support the development of AI-led accelerators in MedTech — e.g., device usage analytics, digital twin for device diagnostics. Assist in positioning the company’s Smart Manufacturing for Devices and AI in QARA offerings in client discussions. Engage in client workshops and internal GTM discussions to shape productized offerings and reusable assets. What You Need Mandatory Qualifications: Bachelor’s or Master’s degree in Biomedical Engineering, Computer Science, or related fields . 10+ years of experience in Digital MedTech, IoMT platforms, Health IT, or embedded medical device software . Deep understanding of IEC 62304, ISO 13485, HIPAA/GDPR, EU MDR, and FDA 510(k) regulations . Experience in cloud-native health solutions (AWS, Azure, GCP) and device-cloud data pipelines. Proven ability to write technical proposals, business use cases, and client-facing whitepapers . Preferred Background: Experience with wearables, drug-delivery devices, and remote patient monitoring systems . Prior work in IT engineering firms supporting large MedTech clients . Hands-on experience with smart device integration, AI/ML for diagnostics, or workflow automation . Strong verbal and written communication skills, with the ability to interface confidently with CxOs and product leaders . What Makes You Eligible Proven leadership in MedTech digital transformation and connected device solutions . Experience working cross-functionally with client teams, product leaders, architects, and engineering groups . Strong background in solutioning for connected care, device-cloud architectures, and regulatory-compliant digital platforms . Demonstrated success in building solution POVs, GTM strategies, and reusable MedTech accelerators .

Role & responsibilities Preparation, Review and updation of Technical Files as per euMDR 2017/745 & DMF as per IMDR. General performance and safety records as per respective Guidelines. Risk Management plan & reports as per respective guidelines. Clinical Evaluation protocol & Report as per respective Guidelines. PMS,PMCF & PSUR plan & report as per respective Guidelines. Design & Development documentation & report as per respective Guidelines. Usability engineering protocol & report as per respective Guidelines. Track & Trend & report all Re-portable events,including serious/ adverse incidence, field safety corrective Keep up to date with national and international legislation,guidelines and customer practice. In absence, charge shall be handed over to the designee.

Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is safer and more secure than the one before. We are a company built on the foundation of challenging and disrupting the way things are done, and we’re looking for innovators who are as committed to shaping the future of cybersecurity as we are. Who We Are We take our mission of protecting the digital way of life seriously. We are relentless in protecting our customers and we believe that the unique ideas of every member of our team contributes to our collective success. Our values were crowdsourced by employees and are brought to life through each of us everyday - from disruptive innovation and collaboration, to execution. From showing up for each other with integrity to creating an environment where we all feel included. As a member of our team, you will be shaping the future of cybersecurity. We work fast, value ongoing learning, and we respect each employee as a unique individual. Knowing we all have different needs, our development and personal wellbeing programs are designed to give you choice in how you are supported. This includes our FLEXBenefits wellbeing spending account with over 1,000 eligible items selected by employees, our mental and financial health resources, and our personalized learning opportunities - just to name a few! At Palo Alto Networks, we believe in the power of collaboration and value in-person interactions. This is why our employees generally work full time from our office with flexibility offered where needed. This setup fosters casual conversations, problem-solving, and trusted relationships. Our goal is to create an environment where we all win with precision. Job Description Your Career We are seeking a driven problem solver to join our Unit 42 MDR team. Our team is responsible for customers internal security monitoring, threat hunting and incident response. As a MDR Analyst, we will rely on you to detect and respond to cyber incidents facing customers’ internal business. The ideal candidate is a quick learner and good communicator who will be able to follow established processes for analyzing threat alerts that fire from our Cortex XDR. The candidate should be a creative thinker who takes pride in solving tough problems. Your Impact Join a new emerging team who is going to be part of Palo Alto’s Unit 42, Working closely with global customers providing the best security in the market Own an incident lifecycle from outbreak to full remediation Provide critical feedback to the different product, research and engineering and threat hunting teams to help improve the products for the entire Palo Alto Networks’ customer base Work closely with Security Research, Threat Intelligence and Threat Hunting teams to remediate and detect new emerging threats This position requires flexibility to work primarily during morning and afternoon hours however, occasional night shifts may be required depending on business demands Qualifications Your Experience 3+ years of experience in a multi tiered SOC/IR is a must Experienced with Technologies such as EDR, SIEM, SOAR, FW A well established familiarity with attack trends and vectors Excellent written and oral communication skills in English Some degree of Malware Analysis or equivalent military experience - An advantage CEH / CompTIA CYSA+ certifications - An advantage Hands-on experience with Cortex XSOAR or Cortex XDR - An advantage Additional Information The Team The team you’ll lead helps protect customers by identifying the most sophisticated & stealthy attacks in their environment. The team does so by leveraging the Cortex product suite as well as unique tools, methodologies and techniques. Cortex provides enterprise-scale detection and response that runs on integrated endpoint, network and cloud data — reduce the noise and focus on real threats. This team works closely with the different product teams and helps improve each and every product by providing first-hand insights into how the product is used and how it can perform even better. Our Commitment We’re problem solvers that take risks and challenge cybersecurity’s status quo. It’s simple: we can’t accomplish our mission without diverse teams innovating, together. We are committed to providing reasonable accommodations for all qualified individuals with a disability. If you require assistance or accommodation due to a disability or special need, please contact us at accommodations@paloaltonetworks.com. Palo Alto Networks is an equal opportunity employer. We celebrate diversity in our workplace, and all qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or other legally protected characteristics. All your information will be kept confidential according to EEO guidelines.

Job description We Are Hiring Senior Executive - Regulatory Affairs For Medical Devices (Orthopedic Implants And Instruments) Role & Responsibilities: 1. Documents Preparation For ISO13485, CE Certificate (As Per EU MDR). 2. Work On Technical Master File. 3. Work On CERs (Clinical Evaluation Report) As Per EU MDR. 4. Work on Risk Management as per EU MDR 5. Have Knowledge About QMS (Quality Management Systems). 6. Reporting To Regulatory Authorities. 7. Conducting Internal Quality Audits. 8. Have Experience Or Knowledge Of European CE (MDD & MDR). 9. Have Knowledge Of USFDA 510K. Skill: 1. Documentation Handling 2. Written & Verbal Communicate Skill 3. Have Good Knowledge Of Computer And MS Office. Education Qualification Of Candidate: B Pharm / M Pharm / Bachelor Or Master Degree In Bio-Medical Engineering / Science Discipline With Training In Medical Devices In Regulatory Affairs Job Types: Full-time, Permanent Job Types: Full-time, Permanent Pay: ₹20,000.00 - ₹45,000.00 per month Benefits: Health insurance Leave encashment Provident Fund Schedule: Day shift Supplemental Pay: Yearly bonus Application Question(s): How many years of experience with ISO - 13485. Do you have knowledge of EU MDR ? Do you have any experience in USFDA - 510. Education: Bachelor's (Preferred) Experience: Medical Devices: 7 years (Required) Work Location: In person Expected Start Date: 24/06/2025

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Responsibilities may include the following and other duties may be assigned: Analyze returned products to identify failure modes and root causes. Conduct detailed assessments of device performance, including physical inspection and functional testing. Document investigation findings in the complaint handling system, ensuring accuracy and completeness. Review complaint data for trends and recurring issues. Identify opportunities for streamlining failure analysis workflows to improve efficiency and accuracy. Contribute to the development and implementation of standardized investigation procedures and tools. Support automation initiatives to reduce manual effort in complaint handling Ensure all complaint investigations comply with regulatory requirements (e.g., MDR, FDA). Maintain detailed and accurate records for audits and inspections. Support internal and external audits by providing investigation data and process documentation. Serve as a subject matter expert (SME) for failure analysis techniques and tools. Stay updated on industry standards and best practices for complaint handling and failure analysis. Train and mentor junior team members in complaint investigation and analysis methods. Monitor and report on key performance indicators (KPIs) related to complaint handling (e.g., FTQ, OCT). Drive improvements to meet or exceed quality and timeliness targets. Required knowledge, experience & skills : Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 4 to 8 years of quality systems experience. Strong communication skills, both oral and written. Ability to understand the functionality / intended use of complex medical devices Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis Comfortable working with international and multi-cultural department and groups in different time zones Accurate and delivers quality work, with a sense of urgency. Ability to work well under pressure and maintain positive, enthusiastic attitude. Ability to work in a fast-paced environment .Eagerness to learn and expand responsibilities & accountability . Skills - Nice to have : Knowledge of medical devices, their development and quality control. Knowledge of FDA, MEDDEV, Canadian Regulations. Technical Writing experience. Good interpersonal skills. Ability to work effectively in a team environment and build strong working relationships. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here

Role Objective: A key objective of this profile is to ensure the effective planning, execution, and documentation of validation and calibration activities, in compliance with regulatory standards and internal policies. The role focuses on maintaining high-quality standards, managing internal and external audits, and ensuring adherence to ISO 13485 and other relevant quality management standards. Additionally, the role supports continuous quality improvement initiatives and ensures that validation activities align with business needs and regulatory requirements. Desired Candidate Profile: Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field. A minimum of 6 years of experience in Quality Assurance within the medical device or pharmaceutical industry. Strong knowledge of validation processes, quality systems, and regulatory standards, such as MDD 93/42/EEC and ISO13485. Experience managing CAPA (Corrective and Preventive Action), conducting risk assessments, and handling internal/external audits. Proven ability to manage validation projects, including scheduling and team coordination. Excellent communication, organizational, and analytical skills. Role & Responsibilities: Plan and execute validation and calibration activities according to the approved schedule, including HVAC, process, transport, sterilization, equipment qualification, and temperature mapping. Coordinate the preparation of PR, PO, material issuance, and service entries for validation-related activities. Provide training to relevant personnel on validation processes and artwork review. Review and compile validation reports from external agencies, ensuring timely approval and payment processing. Verify vendor agreements and certifications, ensuring timely renewals and regulatory compliance. Oversee and ensure the proper execution of QMS activities, including document management and software use (e.g., TrackWise). Participate in line clearance and IPQA (In-Process Quality Assurance) activities as needed. Prepare and review GMP (Good Manufacturing Practice) documents such as SOPs, protocols, and other required documents. Ensure adherence to ISO13485 standards and other relevant regulations. Collaborate with the regulatory department to provide validation and calibration documents as needed for regulatory submissions. Participate in internal and external audits, ensuring timely and accurate documentation submission. Manage PR initiation and closure in TrackWise for qualification and calibration activities. Prepare and execute equipment and utility validation documents as per schedule. Functional Skills Required Expertise in Quality Management Systems (QMS) and validation processes. In-depth knowledge of MDR and other relevant regulatory frameworks. Strong proficiency in CAPA management, auditing, and risk assessment. Technical expertise in process, equipment, and product validation. Ability to manage multiple validation projects and meet strict deadlines. Behavioral Skills Required Strong team management and leadership abilities. Excellent problem-solving and analytical skills. High attention to detail and a commitment to accuracy. Strong interpersonal and communication skills. Ability to collaborate effectively across teams and departments. A proactive approach to continuous improvement and maintaining high-quality standards. Team Size to be Handle: Manage the team of 2-3 team members of Validation & QMS, reporting to AGM-QA. Learn more at: https://www.biotechhealthcare.com Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

Job Title Software Design Quality Engineer Job Description Job Title : Software Design Quality Engineer Job Description In this role, you have the opportunity to Lead on setting Quality and Reliability targets for IGT Systems medical software so that these innovative products deliver high quality and outstanding reliability to the lives they will improve. Next to setting targets, you use your expert Quality and Reliability engineering skills to provide coaching and support to the project team(s) and assure that those targets are achieved. This involves being a confident advisor on quality and reliability engineering topics. You are responsible for Ensure that appropriate project plan and quality plans are made that include all stages of the product’s lifecycle, targets and strategy for a robust software products development. Validates key design inputs including requirements, specifications, useability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy serviceability, sustainability, and costs. Provides effective oversight during the execution of the Quality Plan and any risk management activities, and of all design related activities during the lifecycle. Contribute during design and development to identify critical quality attributes (CTQ, CTS) and ensure that appropriate mitigations and design controls are applied to mitigate the risks. Facilitate design failure mode and effect analysis to identify failure modes early in the design and development process and apply design, manufacturing and inspections to mitigate the risks. Ensure with objective V&V evidences that design output meets the design input. Leading quality related problem solving with the cross functional teams Using post-market data for analytics and statistics to report on the product’s performance in the market (provide feedback to manufacturing, suppliers, or design teams) and initiate field actions when required. Act as a single point of contact (person assigned to) for project team(s); you’re responsible to ensure the product’s design quality related requirements/criteria are complete and meet the quality standards for every project milestone. Make substantial contribution to integrate reliability engineering activities with the medical device development activities. Effective oversight of project deliverables and provide quality input, including safety, efficacy, regulatory. Facilitate the product defect investigations and actions during defect management review meetings. Participate in audits and regulatory inspection as design quality SME and guide other cross-functional stakeholders on technical aspects and audit conduct. You are a part of You will be part of the global Philips Q&R organization and will be reporting within the Design Quality team for IGT-Systems. As member of this team, you contribute to our constant strive for further product quality improvements, so we continuously exceed both internal and external stakeholder expectations. To succeed in this role, you should have the following skills and experience We are looking for a self-motivated and skilled individual who continuously strives for excellence as a way of life, not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people, that Philips improves every year. Specific skill requirements for this role include: Bachelor’s engineering degree with 12 years / Master’s degree with 10+ years of experience; in Software Engineering, quality engineering, SW Quality- or Reliability Engineering role in the medical or aerospace industry. Software testing experience will be an added advantage Ability to define detailed software quality and reliability plans for new medical product developments to ensure those are safe, effective and reliable. Ability to contribute to Risk Management and lead FMEA activities for new products and assurance that control measures are translated in appropriate (critical) requirements. Strong exposure to application of Design Controls; ability to do thorough Design Reviews during new product development to ensure robust designs that further improve patient safety and product quality. Ability to partner with V&V teams to assure thorough Verification, Validation and Useability testing. Analyze development and field data for Product Safety, Quality and Reliability performances and areas for further improvements of Product design and related development processes. Well conversant with statistical data analysis, regression modeling, reliability growth assessment and other quality techniques Experience with adequate and accurate review of DHF and DMR documents. Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304 and ISO 14971. Experience with working in multidisciplinary teams in a high-tech R&D environment. Effective interpersonal, written and oral communication skills expected. Ability and willingness to work onsite About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. How We Work At Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart Our commitment to inclusion and diversity At Philips, we provide equal opportunities to all our employees and to all eligible applicants for employment in our company , irrespective of age, color, disability, nationality, race, religion, gender, sexual orientation (LGBTQ +), and all aspects that make individuals unique. Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair, transparent, and clear employee policies which promote diversity and equality, in accordance with currently applicable law. For, we believe that life is better when #youareyou. Our hybrid working model is defined in 3 ways: We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving. We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips? Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.