606 Mdr Jobs

About OptraSCAN: We are a fast-growing health-tech company focused on building AI-enabled digital pathology solutions that are used by hospitals, laboratories, CROs, and pharma companies in over 30 countries. Our mission is to make precision diagnostics more accessible, efficient, and intelligent. With OptraSCAN , transitioning from conventional microscopy to digital pathology becomes seamless. Our solutions enable effective acquisition of whole slide images, along with features such as viewing, storing, archiving, real-time sharing, and reporting. We offer various pricing models to suit your specific needs and budget. Job Description: OptraSCAN is seeking a highly detail-oriented and knowledgeable Regulatory Specialist – Technical Writer to create, manage, and maintain regulatory documentation required for product approvals, certifications, and market access in global markets. This role involves a combination of regulatory strategy and high-quality technical writing for medical devices (hardware and software), with a focus on ensuring compliance with international standards such as ISO 13485, FDA 21 CFR Part 820, EU MDR, and others. Note: - Apply only if you have experience in IEC 62304 ,IEC 62366, IEC 60601, ISO 14971. Key Responsibilities: Regulatory Documentation & Submissions. Prepare and maintain high-quality regulatory documentation including: Technical Files / Design Dossiers Clinical Evaluation Reports (CERs) Risk Management Files Declarations of Conformity FDA submissions (510(k) or pre-submissions, if applicable) Collaborate with cross-functional teams to gather inputs from R&D, QA, Clinical, and Marketing for submission documents. Technical Writing: Write, edit, and proofread SOPs, work instructions, user manuals, labeling, and IFUs to ensure technical accuracy and regulatory compliance. Translate complex technical data into clear, concise, and user-friendly documentation. Compliance & Standards: Stay current with regulatory changes (EU MDR, FDA, etc.) and update internal documentation and processes accordingly. Ensure documentation aligns with applicable standards such as: ISO 13485 ISO 14971 (Risk Management) IEC 62304 (Software Lifecycle) IEC 62366 IEC 60601 (Electrical Medical Devices) EU MDR 2017/745 FDA 21 CFR Part 820 Quality System Support: Support internal audits and inspections by maintaining complete and audit-ready documentation. Assist in CAPA documentation and post-market surveillance reports when required. Required Qualifications: Bachelor’s or master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field. 2–5 years of experience in regulatory writing or regulatory affairs in a medical device or healthcare product environment. Strong knowledge of global medical device regulatory frameworks (FDA, EU MDR, etc.). Excellent written English and technical writing skills. Strong organizational and project management skills. Preferred Qualifications: Experience preparing 510(k), CE Mark, or similar submissions. Familiarity with digital pathology, imaging devices, or software as a medical device (SaMD). Certification in Regulatory Affairs (e.g., RAPS RAC) is a plus.

ZEISS in India is headquartered in Bengaluru and present in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care and Sports & Cine Optics. ZEISS India has 3 production facilities, R&D center, Global IT services and about 40 Sales & Service offices in almost all Tier I and Tier II cities in India. With 2200+ employees and continued investments over 25 years in India, ZEISS’ success story in India is continuing at a rapid pace. Purpose of this position/Position summary Implement, maintain and further develop the ZEISS India Management System, aligned with the Corporate ZEISS Management System, maintain the ISO 9001 certification requirements, and the business requirements across the pan-India ZEISS organization. Regulate, control and improve the quality of all processes throughout the business and the final product to meet the quality needs of our customers and other stakeholders. Embed a culture of continuous improvement throughout the company. Lead the team to achieve quality management system targets for customers and business goals. Ensure company's products or services comply with all relevant regulations and standards. Act as a bridge between the company and regulatory agencies, navigating complex medical device industry regulatory landscapes to bring products to market and maintain compliance. Primary duties and responsibilities Quality Management : Lead the local development and implementation of management system procedures, systems and initiatives that continuously improve ZEISS systems and product quality levels, aligned with the ZEISS Management System. Responsible for quality related KPI’s, achievement of targets and driving improvements via the Quality team. Integrate quality activities with the Regional and VIS Quality Group and implement VIS requirements. Participate in Regional Quality Group forums, regional quality improvements and benchmarking initiatives. Coordinate with the local Customer Service groups to develop systems that are increasingly responsive to customer requirements and complaints and reduce product write-off levels and avoid further customer losses directly attributable to product quality. Ensure compliance with applicable product regulatory requirements and applicable National or ISO Standards. Responsible for maintaining external certification to ISO 9001, responsible for the internal audit program (system, process & product audits), including audits of other sites as lead or co-auditor, as well as hosting 3rd party & other external audits. Liaise with external bodies on all matters relating to quality. Support New Product introductions and process optimizations. Coordinate product testing activities per Control Plans and Product Audits, and reporting to ensure new products or process changes meet specifications and customer requirements, Be the point person for collecting APQP protocols and report approvals and reports for site products in accordance with agreed procedures. Drive cost-down & improvement projects & initiatives, support the implementation of VIS group quality initiatives and tools. As representative of the customer at VIS, has the authority to stop deliveries and production in case of major product or system non-conformances, with approval / support of the Regional Quality Director or Head Group Quality Management, & aligning with local Management. Corrective and preventive actions using 8D or equivalent methods (from customer reports, audits, etc.). Authority to request from other departments corrective actions in a timely manner. Work closely with all departments in ensuring timely & effective closeout of corrective actions, 8D investigations, nonconformance reports and customer complaints. Responsible for the local Quick Response Quality Control (QRQC) customer complaint system assuring investigation, complaint analysis and definition of the feedback information flow. Coordinate and control the communication with agreed communication channels in Commercial departments. Regulatory Affairs Ensure compliance with all products related regulatory compliances such as (not limited to): Medical device regulations of India and SAARC countries, Medical device regulations of all exporting countries, AERB compliances, Legal metrology compliances, WPC compliances, BIS certifications, MOEF compliances, Drug Sale License etc. Responsible for preparing the regulatory strategy for the organization and support the management to take appropriate decisions. Provides leadership and guidance (including training) to other members of the RA staff as well as to cross-functional team members and development teams. Design, establish and implement a standardized regulatory function processes across the organization. Independently interacts and builds good working relationships with competent authorities. Liaison with the regulator -drugs controlling authority/consultant for the registration of the products. Conducts regulatory due diligence, Identify the business risk and prepares the mitigation plan. Act as the contact person for internal and external regulatory inquiries, including ZEISS internal RA officer networks. Continuously monitor, gather, analyze, assess and communicate regulatory market requirements or changes for India and related local markets. Dimensions : Leadership accountability Leading and motivating employees and functions assigned in technical terms, in order to achieve the set targets with all those involved. Ensure the delivery of the People Strategy within area of accountability. Manage and lead the team, ensuring adequate staffing levels. Motivate and coach the team to operational success. Monitor the completion of tasks and ensure good performance and record on appropriate systems. Consistently promote high standards through personal example and roll-out through the team so that each member of the team understands the standards and behaviors expected of them. Review, implement and update company records e.g. training matrices, performance reviews, risk assessments. Communicate KPIs from the strategic annual plan so that each employee is aware. Provide technical expertise to the team. Manage contractors on site to ensure they meet legal and company requirements. Supervisory dimension Manage, coach and develop a high performing Quality, Regulatory and Process Excellence team that meets agreed objectives, and which delivers best practice results, added value and continuous improvements. Key relationship/customers Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance. Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy. Liaise and communicate with other departments, customers, suppliers and other service providers. Work as part of the Management team to share ideas and improve operation, recommending, supporting and implementing continuous improvement activities and process and procedure improvements to optimize results and improve quality of delivery, in line with quality standards requirements delivery in line with Company and Customer requirements. Communicate with personnel at all levels, internally and externally to the Company, in relation to Quality matters. Key interfaces/liaison/functional guidance within ZEISS group Work closely with Operations, Supply chain, Procurement, Supplier Quality, etc. Support local and global post-market surveillance activities and clinical evaluation. Responsible for the coordination or escalation of critical incidents in the Region and reporting to the regulatory authorities. Provides support for any recall management, RA related complaints management and resulting measures. Support R&D team and digital innovation team to comply with the regulatory requirements. Assists with audits and inspections, if required. Responsible to do the new product assessment and change impact assessment. Obtain a drug license for the distribution of the medical device. Ensure compliance to the Drug sale license or MD42 requirements at all. Job Requirement : 1. Education / Professional Certification Master / bachelor’s degree in science, engineering, business or optical field preferred Lead auditor certification in ISO 13485 / ISO 9001(Optional) Lean Six sigma green belt certified or trained (Optional) 2. Experience At least 10 years experience in working with Quality Assurance and Regulatory affairs in a manufacturing industry. Experienced in Lens manufacturing or medical device Quality and Regulatory management. Should have good experience is leading, mentoring, and guiding the team. Should have a good knowledge and understanding of MSA, APQP, QRQC, 8D, PCP PFMEA, SPC etc. In-depth understanding of medical device regulations which includes but not limited to the followings, the Drugs & Cosmetics Act, the Drugs & Cosmetics Rules, the Medical Device Rules, The Legal Metrology Act and Rules. Sound knowledge of international laws, standards, and regulations for licensing medical devices and of the business processes of medical device manufacturers/import/ sale (e.g., India MDR 2017, MDD/MDR,) Good understanding of Six Sigma methodology and have a mind set of systematic approach to all problems. Good proven experience in conducting management system audits. Experienced in dealing different stake holders and having good communication skill. Advanced written and verbal communication, computer, analytical problem-solving skills are necessary. Demonstrated ability to drive change in a complex and dynamic environment and have ability to solve complex problems within the manufacturing set up. 3. Knowledge / Skills / Other characteristics MS Office, SAP, Minitab, SharePoint, PowerBI, Visio

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 In this exciting role as senior quality engineer , your primary focus responsibility will be managing internal suppliers for released product engineering and ensuring suppliers qualification documents , performance records , change control etc are in accordance with the company requirements. Responsibilities may include the following and other duties may be assigned: Reviews and approves NCMRs as required and needed by the ENT teams. Reviews and approves process and design changes as needed Collaborates on and leads CAPAs as requested and needed by the ENT teams Authors or updates SOPs as requested and needed by the ENT teams Supports the completion of test method validations Works on post-market documents as requested and needed by the ENT teams. This can include but not limited to signal evaluations and HHE (Health Hazard Evaluations) Supports Risk Management File remediation activities as needed Performs Risk Management periodic reviews as needed as well as complaints risk assessments Supports PSUR/CER activities as needed Supports the MDR reportability decision adjustments by performing complaints searches for all products, review for malfunction related serious injuries, and any other activities as identify by the ENT teams. Required knowledge, experience & skills: Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 8 to 12 years of quality systems experience. Strong communication skills, both oral and written. Ability to comprehend principles of engineering, physiology and medical device use. Comfortable working with international and multi-cultural department & 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 . Proficient in the use of Root Cause Analysis Tools Knowledge and application of risk management processes and applicable standards (i.e ISO14971) Experience with statistical techniques 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.

SUMMARY The Security Engineer II GSOC is responsible for all aspects of onboarding and troubleshooting for SentinelOne and AlienVault for all MDR engagements. The Security Engineer II 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 II GSOC supports overall implementation by providing necessary support for current matters. The Security Engineer II GSOC role takes direction on what is needed regarding all aspects of SentinelOne and AlienVault for the engagements. The Security Engineer II GSOC works with the MDR team to support SentinelOne installations, interoperability issues, exclusions, whitelisting, and overall troubleshooting. The Security Engineer II 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 Manages the project governance and leads weekly/monthly status call with client to ensure there are no gaps Acts as the first escalation point of contact to ensure all the issues are tracked and resolved in timely manner Tracks all SentinelOne-related inquiries and tasks for all running projects Trains team members on SentinelOne and its related component and engages with clients as needed to showcase the demonstration of new features Leads technical training and acclimation for clients to familiarize themselves with the SentinelOne interface and functionalities Drives all AlienVault deployments with customers Ensures and creates use case preparation on the tool Develops custom parsers for applications to onboard them to SIEM solutions May perform other duties as assigned by management SKILLS AND KNOWLEDGE General understanding of API queries General understanding of scripting General understanding of developing PowerShell scripts and writing batch files for ad hoc requirements Thorough understanding of Windows and Unix Intervals General understanding of information security Thorough understanding of analysis techniques for reviewing large datasets General understanding of TCP/IP and OSI Model Thorough understanding of the Incident Response Life Cycle (Preparation, Identification, Containment, Eradication, Recovery, Lesson Learned) General 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 Bachelor’s degree and 4-8 years of IT security-related experience or Master’s or advanced degree and 3+ 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) 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. About Us Arete Incident Response is an elite team of the world’s leading cybersecurity and digital forensics experts who combat today’s sophisticated cyberattacks. We work tirelessly to provide unparalleled capabilities and solutions throughout the entire cyber incident life cycle. These include incident response readiness assessments and penetration tests as well as post-incident response, remediation, containment, and eradication services. We work in close collaboration with industry leaders and government agencies along with leading cybersecurity technology platforms to deliver an innovative, intelligence-based approach to solving our client’s toughest challenges. If you want to work with the most talented and experienced people in the industry with the desire to be a cyber hunter and industry expert, we want you to be a part of our team.

Position Summary: The Head of Quality is responsible for overseeing and directing all quality-related functions in the medical equipment manufacturing plant. This includes Quality Assurance (QA), Quality Control (QC), regulatory compliance, and continuous improvement initiatives. The role ensures that all products meet applicable medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820, MDR), internal quality standards, and customer expectations. Location = Himmat Nagar Qualification = B.sc or M.sc Job Types: Full-time, Permanent Pay: ₹50,000.00 - ₹80,000.00 per month Work Location: In person

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 As a Renewal Specialist, you will play a critical role in affecting and operating the renewal process for our existing customer base. You will collaborate with cross-functional teams, such as sales, finance, and customer success, to ensure the successful renewal of customer contracts and maximize revenue opportunities. Ideally, you possess strong people skills, excellent attention to detail, and an understanding of business processes related to customer renewals. Shift timings - 2PM -11PM What you will do Customer Analysis: Analyze Customer Contracts and Product selection related to customer renewals to determine the best renewal path options for customers Customer Engagement: Foster and maintain positive relationships with assigned customers, addressing their inquiries, concerns, and escalations throughout the renewal process. Effectively communicate Sophos renewal offerings Partner Relationship Management: Maintain positive relationships with our top partners, addressing their inquiries, concerns, and escalations throughout the renewal process. Proactively identify and resolve potential roadblocks to the renewal process Revenue Optimization: Drive the process of identifying opportunities for upselling, cross-selling, and expanding customer contracts during the renewal journey. Work closely with the sales team to drive revenue growth from existing customers Process Improvement: Continuously evaluate and refine the renewal process to streamline operations, enhance efficiency, and improve customer experience. Identify automation opportunities and leverage technology tools to optimize workflows Collaboration and Communication: Collaborate effectively with cross-functional teams, including sales, finance, customer success, and product management, to ensure alignment and coordination throughout the renewal process. Clearly communicate renewal status, risks, and opportunities to relevant stakeholders What you will bring Fluent English Language Skills Bachelor’s degree in business administration, Communications, or Marketing preferred; or proven relevant experience in previous roles Experience in Sales, Customer Success, Channel Partners, or Renewal Management preferred Familiarity with Salesforce tools such as Lightning and CPQ, as well as additional tools like Outreach, Microsoft Excel, Microsoft Power BI, and Microsoft Outlook Excellent attention to detail and organizational skills, ensuring accuracy in contract management and communications Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and build relationships with customers A self-motivated and proactive approach to a set of tasks, with the ability to work independently and prioritize tasks effectively Experience in the technology industry or a SaaS-based organization is highly desirable Familiarity with contract management processes and legal terminology is a plus #B1 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

Summary The Security Engineer II GSOC is responsible for all aspects of onboarding and troubleshooting for SentinelOne and AlienVault for all MDR engagements. The Security Engineer II 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 II GSOC supports overall implementation by providing necessary support for current matters. The Security Engineer II GSOC role takes direction on what is needed regarding all aspects of SentinelOne and AlienVault for the engagements. The Security Engineer II GSOC works with the MDR team to support SentinelOne installations, interoperability issues, exclusions, whitelisting, and overall troubleshooting. The Security Engineer II 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 Manages the project governance and leads weekly/monthly status call with client to ensure there are no gaps Acts as the first escalation point of contact to ensure all the issues are tracked and resolved in timely manner Tracks all SentinelOne-related inquiries and tasks for all running projects Trains team members on SentinelOne and its related component and engages with clients as needed to showcase the demonstration of new features Leads technical training and acclimation for clients to familiarize themselves with the SentinelOne interface and functionalities Drives all AlienVault deployments with customers Ensures and creates use case preparation on the tool Develops custom parsers for applications to onboard them to SIEM solutions May perform other duties as assigned by management Skills And Knowledge General understanding of API queries General understanding of scripting General understanding of developing PowerShell scripts and writing batch files for ad hoc requirements Thorough understanding of Windows and Unix Intervals General understanding of information security Thorough understanding of analysis techniques for reviewing large datasets General understanding of TCP/IP and OSI Model Thorough understanding of the Incident Response Life Cycle (Preparation, Identification, Containment, Eradication, Recovery, Lesson Learned) General 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 Bachelor’s degree and 4-8 years of IT security-related experience or Master’s or advanced degree and 3+ 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) 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.

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. Job Description Are you ready to take your career to the next level? If you have a strong background as a Product Assessor within an EU notified body conducting MDD/MDR technical documentation review, then we have an exhilarating opportunity for you! Join our dynamic team at SGS and become a Senior Product Assessor - Active Devices. This role will allow you to make a significant impact in the field of certification. As a member of our Medical Device team, you will not only manage a small team of globally based Product Assessors but also dive deep into the exciting world of Active Medical Devices. Your responsibilities will include: Supporting and guiding your team of talented Product Assessors Conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards. Collaborating with cross-functional teams to increase efficiency and quality Monitoring the team's technical competence, KPIs, and wellbeing and providing feedback and support when there are concerns. Conduct recruitment, including reviewing CVs and undertaking interviews and supporting with onboarding of new starters Develop training and present the training to others in SGS or externally as deemed necessary. Assist with technical queries and those related to sales within the Active Medical Devices field. Ensure that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery. Qualifications For application, please submit English CV. To be eligible for this role, you should have prior experience as a Product Assessor/Specialist/Technical File Reviewer within another Notified Body for active devices, conducting reviews against MDD and/or MDR. Additionally, you must possess: Four years of professional experience in the field of healthcare products or related activities, such as design, manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed Active Medical Devices knowledge (monitoring equipment, therapeutic devices, devices utilizing radiation, stand-alone software devices, etc.) through designing, manufacturing, or testing of such devices Thorough knowledge and understanding of related standards: EN 60601, EN 62304, EN 62366, etc. Good written English skills (as reports will be reviewed/queried in English) Knowledge of the following Technical File codes desirable (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017): MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318. Additional Information Why SGS? Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry. Enjoy a flexible schedule and remote work model. Access SGS University and Campus for continuous learning options. Thrive in a multinational environment, collaborating with colleagues from multiple continents. Benefit from our comprehensive benefits platform. Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.

Job Title: Presales Consultant Job Location: Mumbai (Thane / Andheri) Job Purpose: We are looking for a motivated Presales Consultant to support the sales and solutioning efforts across our cybersecurity service lines — including Assessment, GRC, MDR, CES, and MSSP offerings. This individual will assist in crafting tailored solutions, preparing responses to client requirements (RFPs/RFIs), conducting demos, and supporting technical engagements. The role requires a solid foundation in cybersecurity frameworks and technologies, a consultative mindset, and the ability to work collaboratively with cross-functional teams. Roles & Responsibilities 1. Solution Support & Technical Enablement Assist in understanding client requirements and support the design of relevant cybersecurity solutions. Participate in product demonstrations, technical presentations, and proof-of-concept (PoC) activities. Collaborate with technical teams to gather solution inputs, align service capabilities, and ensure delivery feasibility. 2. Proposal & Documentation Support Contribute to the preparation of RFP/RFI responses, technical proposals, and solution documents. Support the development of case studies, technical decks, and value propositions aligned to client needs. Maintain documentation repositories and templates for proposals and solution descriptions. 3. Sales Coordination & Client Engagement Work closely with the sales team to support opportunity scoping and technical positioning. Join client meetings to explain solution components and clarify technical queries. Support objection handling and help define the technical scope of engagements. 4. Research & Intelligence Conduct research on emerging technologies, industry trends, and competitor offerings. Contribute to internal knowledge bases and solution playbooks. Assist in identifying potential upsell and cross-sell opportunities during presales discussions. 5. Collaboration & CRM Updates Coordinate with internal teams (delivery, compliance, product, and marketing) for aligned solutioning. Ensure CRM tools (e.g., Zoho, Salesforce, HubSpot) are updated with relevant opportunity and proposal data. Track and report on proposal status, win/loss insights, and customer feedback. Skills / Knowledge Required: Understanding of cybersecurity frameworks like ISO 27001, NIST, SOC 2, etc. Familiarity with cybersecurity technologies — SIEM (Splunk, QRadar), EDR, IAM/PAM, firewalls, and cloud security (AWS, Azure, GCP). Proficiency in Microsoft Office (Word, PowerPoint, Excel); basic proposal formatting and content creation skills. Excellent written and verbal communication. Exposure to RFP/RFI processes and presales documentation preferred. Experience: 3+ years of experience in a Presales, solution engineering, or technical consulting role in IT or cybersecurity services.

Job Title Senior Design Quality Engineer Job Description Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most. The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs. You are responsible for Ensures that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design Validates key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle Performs independent technical assessment on product quality performance and post-market product quality analysis. Can Lead quality related problem solving and root cause analysis during design and manufacturing Uses post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required. Performs independent technical assessment on product quality performance and post-market product quality analysis Provide leadership and oversight to ensure Quality Management System Compliance Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems Ensure the compliance requirements are met during Design review , design verification & Design validation , Design transfer Apply and facilitate Design for Quality & Reliability best practices (FMEAs, robust design, V&V, root cause analysis & problem solving) You are a part of The Philips Hospital Respiratory Care business group, supporting products including invasive and noninvasive hospital ventilators, patient interfaces, sensors, and monitoring equipment. We believe that by understanding our customers’ problems we can ease the discomfort of ventilation by providing innovative solutions to improve the patient-ventilator experience, permit speech, and speed liberation. These technological breakthroughs allow the clinician to concentrate more on the patient and less on the device. To succeed in this role, you’ll need a customer-first attitude and the following Bachelor’s Engineering degree with 12+ years of related experience or Master’s degree with 5+ years of related experience -Mechanical/ Electrical/ Electronic or Equivalent Engineering Engineering Degree or equivalent experience in medical device industry 5+ years’ experience with a medical device company preferably Can Lead quality related problem solving and root cause analysis during design and manufacturing Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.) Experience or understanding of Software or Hardware development, Verification and Validation, Risk management, RCA, Requirements Management, Design, Usability. Have an understanding of Sample Size Determination and Statistical Methods , Safety Risk Management (i.e ISO 14971) and Failure Modes and Effects Analysis (FMEA) / Fault Tree Analysis-. Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements. Have an understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up. Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving. In return, we offer you A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities. 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 – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. 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.

Job Title: Sales Associate Job Location: Mumbai (Thane) / Pune Job Overview: We are seeking a motivated and customer-focused Sales Associate to support the sales team in driving revenue growth and building strong relationships with prospective clients in the cybersecurity domain. This role involves lead generation, client engagement, proposal support, and close coordination with technical and marketing teams to deliver cybersecurity solutions tailored to client needs. Key Responsibilities: Assist in identifying and qualifying potential clients through cold calling, networking, and research. Maintain and update CRM with prospect information and sales activities. Understand the company’s cybersecurity offerings (MDR, GRC, Assessments, etc.) to effectively pitch and present solutions. Coordinate and schedule client meetings, product demos, and presentations. Support in proposal creation, pricing, and documentation. Follow up with leads and nurture client relationships to move opportunities through the sales funnel. Collaborate with pre-sales and delivery teams to align solutions with client requirements. Stay updated on cybersecurity trends, services, and competitor offerings. Meet or exceed monthly and quarterly lead generation and sales targets. Requirements: Bachelor's degree in Business, IT, Cybersecurity, or related field. 1–3 years of experience in B2B sales or inside sales (tech or IT preferred). Strong communication, interpersonal, and presentation skills. Familiarity with cybersecurity concepts is a plus (training can be provided). Proficient in using CRM tools (e.g., Zoho, Salesforce, HubSpot). Self-driven, proactive, and able to work in a fast-paced environment.

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 In this exciting role as senior quality engineer , your primary focus responsibility will be managing internal suppliers for released product engineering and ensuring suppliers qualification documents , performance records , change control etc are in accordance with the company requirements. Responsibilities may include the following and other duties may be assigned: Reviews and approves NCMRs as required and needed by the ENT teams. Reviews and approves process and design changes as needed Collaborates on and leads CAPAs as requested and needed by the ENT teams Authors or updates SOPs as requested and needed by the ENT teams Supports the completion of test method validations Works on post-market documents as requested and needed by the ENT teams. This can include but not limited to signal evaluations and HHE (Health Hazard Evaluations) Supports Risk Management File remediation activities as needed Performs Risk Management periodic reviews as needed as well as complaints risk assessments Supports PSUR/CER activities as needed Supports the MDR reportability decision adjustments by performing complaints searches for all products, review for malfunction related serious injuries, and any other activities as identify by the ENT teams. Required knowledge, experience & skills: Bachelors degree in Engineering, Science, or Technical Discipline required and Minimum of 8 to 12 years of quality systems experience. Strong communication skills, both oral and written. Ability to comprehend principles of engineering, physiology and medical device use. Comfortable working with international and multi-cultural department & 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 . Proficient in the use of Root Cause Analysis Tools Knowledge and application of risk management processes and applicable standards (i.e ISO14971) Experience with statistical techniques 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

Title: Executive - Biotechnology Date: Jul 29, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Job Objective Searching for highly motivated candidate having technical expertise in Biosimilar product analysis. Key Responsibilities: The candidate is expected to develop HPLC based methods for protein and peptide products. The candidate is expected to design and implement integrated strategies, linking appropriate analytical tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on RP-HPLC, SEC-HPLC, CEX-HPLC..etc Responsible for designing advance workflows to measure & characterize process related impurities at different stages of product development such as Host cell protein (HCPs), Host Cell DNA (HCD) & Leachable. The candidate is expected to qualify the methods for intended purpose for all pipeline products. Responsible for routine in process sample analysis. Responsible for 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. Responsible for managing the regulatory queries. The candidate is expected to draft the technical content for regulatory dossier. Educational Qualification: M.SC. in Biochemistry / Life Sciences / Biotechnology. Technical/functional Skills: Sound knowledge of analytical method development, qualification. Experience in biosimilar development for regulated market is desirable. Experience of analytical development for monoclonal antibodies and peptide is highly desirable.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position We are seeking a knowledgeable and experienced ISO 13485 Quality Management Expert to lead and support the implementation, and maintenance of our Quality Management System (QMS) in compliance with ISO 13485:2016, MDSAP and relevant regulatory requirements. The ideal candidate will play a key role in ensuring that our medical device products meet the highest standards of quality and safety. Lead the development, implementation, and continuous improvement of the QMS in accordance with ISO 13485 and applicable regulatory requirements (e.g., FDA 21 CFR Part 820, MDR) Prepare for and manage internal and external audits (including notified body, regulatory agency) Conduct risk assessments, gap analyses, and process validations Ensure proper documentation, training, and compliance across all quality-related functions Support the creation and revision of SOPs, work instructions, forms, and other quality documents Collaborate with cross-functional teams (engineering, regulatory affairs, Global Q&R etc.) to ensure product and process quality throughout the lifecycle Monitor quality KPIs and prepare reports for management review Identify and lead corrective and preventive actions (CAPAs), non-conformances (NCs), and root cause analyses (RCAs) Provide ISO 13485 and QMS training to employees at all levels Monitor training compliance for the site 5+ Years experience; recognised internally as an expert in own job discipline Bachelor’s / Master degree in Life Science, Data Science, Engineering or related subject or equivalent experience. Experience working in a Software as a Medical Device (SaMD) environment is preferred In-depth knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 82304, FDA, QSR, EU-MDR and legislation for Software as a Medical Device or IVD. Knowledge of ISO 27001 family of standards, HITRUST, HIPAA and GDPR will be an advantage Experience in preparing for and participating in audits and inspections Strong analytical, problem-solving, and communication skills Certification in ISO 13485 auditing (e.g., Lead Auditor) is preferred Familiarity with electronic QMS systems and tools is a plus Has worked in more than one function within quality management and may have worked outside of Quality Management. Can manage highly complex and/or global projects, or equivalent experience Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership. Job Description As a Product Assessor , you will be responsible for conducting comprehensive assessments of Soft Tissue products, ensuring technical file reviews adhere to all applicable requirements, including the European Medical Device Regulation (MDR), Medical Device Directive (MDD), and UKCA for Class IIa/IIb and/or Class III devices. Your role will involve ensuring that these assessments are technically sound and compliant with relevant regulations. You will also: Support CE marking activities carried out by SGS. Contribute to the training and qualification of junior staff, including the creation of training materials. Communicate effectively with team members and clients regarding product assessments, working to minimize risks associated with medical device certification and maintenance. Qualifications: The ideal candidate will have extensive experience in healthcare products or related activities, such as design, manufacturing, regulation, auditing, or research. Specific experience in the design, manufacture, testing, or use of Soft Tissue devices is required. Preferred Experience: Experience conducting Soft Tissue Product Assessments for another Certification/Notified body (Technical File reviewer) is advantageous. Education : Degree or equivalent qualification in a relevant discipline such as medicine, pharmacy, engineering, or other related sciences. Skills : Strong communication skills, especially through electronic mediums. Proficiency in written and verbal English, as reports will be reviewed and queried in English. In-depth knowledge of medical devices within the following non-active categories (as per Commission Regulation 2017/2185): MDN 1104 – Non-active soft-tissue and other implants (e.g., IUDs, urethral stents, bariatric devices, biliary stents). Specifically long term invasive implants such as IUDs, ophthalmic devices, and surgical sutures. MDN 1202 – Non-active non-implantable devices for administration, channelling, and removal of substances (e.g., dialysis devices, intravenous lines, hypodermic needles, catheters). Specifically non-invasive channelling and storing devices such as blood bags or similar. MDN 1206 – Non-active non-implantable ophthalmologic devices (e.g., contact lenses, eye drops, other instruments for ophthalmological surgery). MDN 1214 – General non-active non-implantable devices used in healthcare (e.g., ultrasound gels). For your CV to be reviewed please send it in English. Additional Information Why SGS? Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry. Enjoy a flexible schedule and work model. Access SGS University and Campus for continuous learning options. Thrive in a multinational environment, collaborating with colleagues from multiple continents. Benefit from our comprehensive benefits platform. Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.

About the Role: We are seeking a motivated and detail-oriented QMS & Regulatory Affairs Specialist to join our growing regulatory team. This position is ideal for individuals with 1–5 years of experience in medical devices, particularly those familiar with Software as a Medical Device (SaMD) . You will play a key role in ensuring compliance with global regulatory requirements and maintaining an effective Quality Management System (QMS). Responsibility: Support implementation and maintenance of ISO 13485:2016 compliant QMS processes. Assist in regulatory submissions (e.g., FDA 510(k) , EU MDR , India CDSCO ) for SaMD and other medical devices. Prepare and maintain regulatory documents including technical files, design dossiers, and labeling materials. Collaborate with cross-functional teams (engineering, product, clinical) to ensure regulatory and quality compliance from design through post-market. Support risk management activities in line with ISO 14971 and software lifecycle documentation under IEC 62304 . Conduct internal audits, gap assessments, and assist in external audits or inspections. Maintain QMS documentation including SOPs, work instructions, CAPAs, and training records. Track and interpret changes in regulatory standards and implement updates accordingly. Required Skills Bachelor’s degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field. 1–5 years of relevant experience in QMS and regulatory affairs within the medical device or SaMD domain . Good understanding of ISO 13485 , IEC 62304 , ISO 14971 , and related standards. Exposure to regulatory pathways in FDA, EU MDR, and/or CDSCO . Strong technical writing skills Detail-oriented with excellent communication

🧾 Job Title: Regulatory Affairs Specialist – Medical Devices (2–5 Years Experience) Location: Navi Mumbai Reports to: Regulatory Affairs AGM Job Summary: We are looking for a Regulatory Affairs Specialist with 2 to 5 years of hands-on experience in the medical device industry , specializing in regulatory submissions for the US (FDA) and European Union (EU MDR 2017/745) . You will be responsible for preparing and maintaining high-quality regulatory submissions and technical documentation, ensuring compliance across product lifecycles and markets. Key Responsibilities: US (FDA) Regulatory Support: Prepare and submit: 510(k) premarket notifications PMA supplements or De Novo requests (if applicable) Support establishment registration and device listing Ensure compliance with 21 CFR Part 820 (QSR) and UDI requirements Collaborate with the Quality team during FDA inspections EU Regulatory Support: Compile and maintain Technical Documentation in accordance with EU MDR 2017/745 Prepare and manage: CE marking submissions SSCPs (Summary of Safety and Clinical Performance) Declaration of Conformity Coordinate with Notified Bodies and participate in audits Assist in Post-Market Surveillance (PMS) , Vigilance reporting , and Periodic Safety Update Reports (PSUR) Cross-Functional & Strategic Support: Act as a Regulatory Affairs representative in Product Development Teams (PDT) Review and approve labeling, IFUs, promotional material, and packaging for regulatory compliance Participate in Change Control and assess regulatory impact globally Monitor evolving regulations (e.g., MDCG guidance, FDA guidance) and communicate impact to internal stakeholders Qualifications: Bachelor's degree in Pharmacy , or a related discipline 2–4 years of experience in Regulatory Affairs in the medical device industry Experience with Class I or II medical devices under FDA and EU MDR Solid understanding of: 21 CFR 807, 812, 814, 820 EU MDR Annexes II & III , and ISO 13485:2016 Key Skills & Tools: Regulatory submissions (510(k), CE Marking, EU MDR documentation) Use of tools like eSTAR (FDA) , EUDAMED , or Regulatory Information Management (RIM) systems Strong technical writing and documentation skills Experience working with Notified Bodies and/or FDA reviewers Excellent organizational, problem-solving, and communication skills Ability to work cross-functionally in a matrix environment What We Offer: Exposure to global regulatory strategies and cross-border product registrations Opportunity to work on innovative Class I/II medical technologies Career growth path in Regulatory Affairs & Quality Management Collaborative, fast-paced work environment Kindly share your resume at amits@firsttimeusgenerics.com and/or sujitkumarfirke@firsttimeusgenerics.com

Job Objective Searching for highly motivated candidate having technical expertise in Biosimilar product analysis. Key Responsibilities The candidate is expected to develop HPLC based methods for protein and peptide products. The candidate is expected to design and implement integrated strategies, linking appropriate analytical tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on RP-HPLC, SEC-HPLC, CEX-HPLC..etc Responsible for designing advance workflows to measure & characterize process related impurities at different stages of product development such as Host cell protein (HCPs), Host Cell DNA (HCD) & Leachable. The candidate is expected to qualify the methods for intended purpose for all pipeline products. Responsible for routine in process sample analysis. Responsible for p reparation and review of method development reports (MDR) and analytical test procedures (ATP). Responsible for operating and maintaining analytical laboratory in compliance with GLP regulations. Responsible for managing the regulatory queries. The candidate is expected to draft the technical content for regulatory dossier. Educational Qualification M.SC. in Biochemistry / Life Sciences / Biotechnology. Technical/functional Skills Sound knowledge of analytical method development, qualification. Experience in biosimilar development for regulated market is desirable. Experience of analytical development for monoclonal antibodies and peptide is highly desirable.

Ankura is a team of excellence founded on innovation and growth. Location: Conditional Remote / Gurgaon Hours: 40 hours a week Reporting: Director - Threat Detection Operations (TDO) Duties include providing On-Job Training to fellow Senior Analysts and Analysts, continuous monitoring of Security Information Event Management (SIEM), EDR, XDR and related platforms for correlated events and alerts and working with the client to take action. Senior Analysts leverage events to determine the impact, document possible causes, and provide useful information to clients. A deep understanding of various commercial and open-source network sensors, intrusion detection systems, and event log correlation engines is required as senior analysts are expected to deliver enhanced threat awareness and knowledge through research and continuous improvement of use cases, signatures, and metrics. Expected to help automate anomaly detection and alerting while documenting security incidents, processes, investigations, and remediation efforts. Senior Analysts are also expected to maintain open communication and visibility with their team members, Directors, and Clients. Usually, employees will be permitted to work remotely in the current operational setup however that setup may change based on company and/or business needs, with or without notice. It may also be considered a conditional privilege as the employees are personally responsible to maintain uninterrupted availability and communication via all official channels throughout their designated shifts. If the employee's performance cannot be satisfactorily ascertained by their manager or the employee is unable to adapt to work without disturbance, they may be called upon to work out of the company’s office. CAPABILITIES Knowledge of IR process, ticketing tools, Knowledgeable in various IR response commands related to Windows, Linux Strong knowledge on advanced attack techniques related to Endpoints and servers, Threat hunting using EDR/XDR. Experience in handling latest attack techniques LOLBAS, fileless malware etc. Experience in monitor globally emerging threats, vulnerabilities, malicious activities etc. research about the same and reports to concerned teams and management for proactive actions. Must have knowledge of various OSINT tools: VirusTotal, Cisco Talos Intelligence, IBM X-force Exchange, URL.io etc. during the investigation of security alerts. Capable to handle a team of L1 analysts, impart training etc Must have experience of Vulnerability management to identify emerging risks in organization's environment using Qualys, Nessus, MS-Defender etc Knowledgeable about Automation and SOAR Must have the necessary experience to conduct initial triage and in depth analysis of security events and incidents; determine the priority, criticality, and impact; facilitate communication within the client's SOC, escalate to the for containment and remediation, and document/journal progress throughout the Incident Response Lifecycle within the respective service level objectives. Required to have experience in conducting research analysis and data gathering requirements to present in a report format. Should be detail-oriented and able to work independently and communicate effectively both verbally and in writing.Must be flexible enough to work in a 24x7 rotational shift setup, including overnight, weekend, and national holidays. TECHNICAL Emerging SIEM/XDR such as MS Azure Sentinel, SentinelOne Experience with security tools: Nessus, Burpsuite, Acunetix, Kali Linux Strong knowledge on XDR tools such as Sentinel One, Cortex, CrowdStrike, Microsoft etc Understanding of KQL, Lucene, Python, and/or other similar programming/query/scripting languages Proficient in finetuning detection rules of XDR, creation of SOPs, Playbooks for various scenarios and techniques EDUCATION, EXPERINCE, TRAINING & CERTIFICATIONS Minimum Experince in SOC/IR/VM 4 yrs plus Preferred to have a degree in CS/IT or a Masters's Diploma in the field of IT Security. Certifications such as CEH, Security+ CHFI,ACE, and specific to vendor XDR tools SentinelOne cortex, Microsoft CrowdStrike etc COMMUNICATION Comfortable working in a remote work environment including web-based team management and collaboration applications, and time-keeping systems e.g. Slack, Microsoft Teams, Intapp, and Workday. Ability to communicate complex ideas effectively, both verbally and in writing in English and the local office language(s) Able to provide reports showing progress or achievement of assigned goals and responsibilities as required. Must be an active listener and ask questions of others when clarity is needed Ability to gain an understanding of client needs and apply analytic reasoning Demonstrates proactive engagement in meetings and process discussions KEY PERFORMANCE INDICATORS Analyze client networks for threats using analytical platforms for event monitoring such as NSM, SIEM, UEBA, ETDR. Deliver client reports based on analyses that are timely, high quality, and accurate. Understand and support incident response and triage Improve reporting to avoid ‘analysis paralysis’. Develop new skills within analytical platforms INDIVIDUAL & TEAMWORK Must be able to effortlessly switch between independent and team-based work Understands that the work product is dependent on team efforts and remains responsive to internal and external deadlines Able to share expertise and experience with team members to encourage growth and shared success Able to maintain focus and attention to detail for sustained periods of time Engaged in supporting the development and growth of all team members GROWTH MINDSET Can receive and provide feedback in a constructive manner that leads to the growth of self and others. Displays perseverance of effort and passion for a long-term goal and end state. Works well under timelines and puts in extra effort as required to meet timelines. Self-motivated to identify areas for team & process improvement and collaborate with others to develop creative solutions LEADERSHIP TRAITS Willing to adapt leadership skills to support larger and more complex projects. Work product for self and team is consistently of excellent quality and efficiency. Respectful and professional in all interactions with team members, clients, and colleagues. Maintains composure and calm disposition under high-pressure or stressful circumstances. #LI-JK1 Ankura is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. Equal Employment Opportunity Posters, if you have a disability and believe you need a reasonable accommodation to search for a job opening, submit an online application, or participate in an interview/assessment, please email accommodations@ankura.com or call toll-free +1.312-583-2122. This email and phone number are created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues unrelated to a disability, will not receive a response.

We are seeking a Cloud Engineer to design, implement, and maintain cloud infrastructure (AWS, Azure, GCP). Key responsibilities include cloud architecture, system administration, automation, security, cost management, and documentation. Experience with migrating Exchange and SharePoint to cloud solutions is required. Collaborate with, cross-functional teams to design, implement, and maintain cloud infrastructure solutions. Provide technical guidance and support to resolve complex issues related to cloud services, Cyber Security, Networks. Perform regular assessments and audits to ensure the security, reliability, and efficiency of cloud environments. Participate in planning and executing cloud migration projects, including workload assessments, resource provisioning, and data migration strategies. Work as a Technical Consultant for Various Microsoft Technologies and its Security products. Hosted Exchange and Online Exchange Migration SharePoint and OneDrive Migration Teams, Enterprise Roaming Profile and Intune Deployment Spam Filters and Endpoint Security, EDR, XDR, NDR, MDR Work with Pass-through, Federated auth, SSO, Hybrid access, Cloud Sync, Delegation, Self Service. MFA, Conditional Policies, PIM, Vulnerabilities and risk assessment. Encryption, Risk Asses, Incidence management, VA, Penetration test, IDS/IPS, compliance

Job Title Data Engineering Expert Job Description Job title: Data Engineering Expert Your role: As a Data Engineer Expert, you will be instrumental in designing, developing and maintaining robust data pipelines and systems to support patient safety and quality activities. You will work primarily with product and post market surveillance data, utilizing Azure and Databricks to ensure that we can monitor the performance of devices while meeting regulatory requirements. Your Role Design, Build, and Maintain Data Pipelines: Develop and maintain scalable, reliable, and efficient ETL (Extract, Transform, Load) pipelines using Azure tools and Databricks to handle large datasets from medical devices in the field. Data Integration: Integrate data from various sources (e.g., medical devices, regulatory systems, clinical databases) into centralized data lakes or data warehouses using Azure Data Factory, Databricks, and other relevant tools. Collaborate and work with Cross-Functional Teams: Work closely with clinical, regulatory, and quality assurance teams to ensure that data collected meets regulatory requirements (e.g., FDA, ISO 13485, MDR) and supports post-market surveillance activities. Data Security and Compliance: Ensure all data systems comply with industry regulations and data privacy standards. Continuous Improvement: Stay up-to-date with the latest advancements in data engineering, cloud technologies (specifically Azure), and medical device industry trends, and proactively suggest improvements to existing systems. You're the Right Fit If You Have: A Master’s degree in Computer Science, Data Science, or a related field. A Minimum of 6-7 years of experience as a Data Engineer or in a related role, with a focus on data integration, ETL processes, and database management. Strong proficiency in Python and SQL, with hands-on experience in writing complex SQL queries and Python scripts for data processing.- MANDATORY Experience with Azure cloud services, including Azure Data Factory, Azure SQL Database, Azure Data lake and Databricks. 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 – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. 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.

Inside Sales Representative (ISR) – Compliance & Cybersecurity Location: Mumbai Job Summary As an Inside Sales Representative (ISR) at CyberSigma, your role will be to drive revenue growth by proactively engaging with leads and prospects in regulated industries such as fintech, healthcare, SaaS, and e-commerce. You'll focus on identifying customer needs, promoting our cybersecurity and compliance services, and closing deals through strategic outreach. You will work closely with Regional Sales Managers, Solution Architects, and the Marketing team to convert inbound interest into long-term clients and expand the reach of CyberSigma's compliance and security offerings. Key Responsibilities Conduct high-volume outbound calling, email campaigns, and virtual meetings to generate qualified leads. Drive the sales process for cybersecurity compliance services including PCI DSS, ISO 27001, SOC 2, GDPR, HIPAA, DPDPA, and VAPT audits and consulting. Qualify prospects through discovery calls and needs assessments. Schedule demos and consultations for senior sales or technical consultants. Follow up on marketing-generated leads and events/webinars. Support proposal creation and respond to client RFPs or RFIs. Coordinate with Regional Sales Managers on territory strategy and account penetration plans. Achieve and exceed monthly and quarterly sales targets. Compliance standards : PCI DSS, ISO 27001/27701, SOC 1 & SOC 2, HIPAA, GDPR, DPDPA, NIST, etc. Security Testing : VAPT (Web, Mobile, Infra), Red Team exercises. Managed Services : GRC automation tools, MDR, SIEM/SOC offerings. Qualifications & Skills 2–5 years of B2B inside sales or lead generation experience (cybersecurity or compliance domain preferred). Strong understanding of cybersecurity frameworks, risk management, and regulatory compliance services is a major plus . Demonstrated ability to manage full sales cycle or handoff after qualification. Excellent written, verbal, and interpersonal communication skills. Strong organizational skills with attention to detail and follow-through. A self-starter with a results-driven approach and the ability to work independently. Bachelor’s degree preferred (in Business, Marketing, Information Security, or related fields).

Job Title Data Engineering Analyst Job Description Job title: Data Engineering Analyst Your role: As a Data Engineer Analyst, you will be instrumental in designing, developing and maintaining robust data pipelines and systems to support patient safety and quality activities. You will work primarily with product and post market surveillance data, utilizing Azure and Databricks to ensure that we can monitor the performance of devices while meeting regulatory requirements. Your Role Design, Build, and Maintain Data Pipelines: Develop and maintain scalable, reliable, and efficient ETL (Extract, Transform, Load) pipelines using Azure tools and Databricks to handle large datasets from medical devices in the field. Data Integration: Integrate data from various sources (e.g., medical devices, regulatory systems, clinical databases) into centralized data lakes or data warehouses using Azure Data Factory, Databricks, and other relevant tools. Collaborate and work with Cross-Functional Teams: Work closely with clinical, regulatory, and quality assurance teams to ensure that data collected meets regulatory requirements (e.g., FDA, ISO 13485, MDR) and supports post-market surveillance activities. Data Security and Compliance: Ensure all data systems comply with industry regulations and data privacy standards. Continuous Improvement: Stay up-to-date with the latest advancements in data engineering, cloud technologies (specifically Azure), and medical device industry trends, and proactively suggest improvements to existing systems. You're the Right Fit If You Have: A Bachelor's degree in Computer Science, Data Science, or a related field. A Minimum of 2-5 years of experience as a Data Engineer or in a related role, with a focus on data integration, ETL processes, and database management. Strong proficiency in Python and SQL, with hands-on experience in writing complex SQL queries and Python scripts for data processing.- MANDATORY Experience with Azure cloud services, including Azure Data Factory, Azure SQL Database, Azure Data lake and Databricks. 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 – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. 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.

Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. In BD Specimen Management (SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career. Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Our people make all the difference in our success. Join us in our mission to advance the world of health. Support the Regulatory Affairs function on Product Lifecycle Management (PLM)/Sustaining project teams and liaise with Regulatory Affairs subject matter experts (SMEs) to fulfill US FDA and EU CE requirements. Assist in compiling, drafting and submitting the required submission documents to support 510(k) and/or CE Technical File Documentation, (eg STeD ) to obtain clearances and/or approvals to established timelines. Assist and manage Notification of Change (NOC)/International Regulatory Affairs assessments of PLM/Sustaining activities to ensure regional/country requirements of US, EU and Rest of World (ROW) are captured in Regulatory strategy development. Develop regulatory strategies for Change Controls (CC) and establish Regulatory Requirements. Monitor completion of all CC task requirements recorded in the PEGA CC system and verify completion of requirements before Engineering Change Release ECRO release. Monitor and assess the impact of existing, modified and new standards pertaining to BD products for the US and EU markets and maintenance of related regulatory documentation. Support regulatory efforts to maintain and /or simplify technical documentation maintenance, labeling changes/remediations projects and UDI assessments. Review and approve labeling and promotional material for compliance to FDA and EU regulations. Support completion of EU Substantial Change Notifications and Substantial Change Applications for approval. Prepare responses to notified body inquiries. Prepare EU CE re-certification applications following notified body templates with supporting evidence from cross functional teams. Provide training or deliver presentations to cross-functional groups across TCI and SM on salient regulatory topics. Recognize potential compliance problems areas or associate ambiguity and make recommendations to resolve. Work independently and carries out the above tasks with minimal supervision. Education and Experience: B.S. degree in a scientific, health sciences or technical discipline (e.g., engineering, bioengineering, biology, chemistry). Minimum 5 years regulatory experience and working knowledge in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree. Experience in preparing, approving and maintaining Technical Documentation and other submissions compliant with US, EU and global regulations. Experience in supporting product development projects for product and process changes. Demonstrated ability to participate on cross-functional team to consistently to meet regulatory requirements and project timelines. Proficient in using Microsoft Word, Excel, PowerPoint, and Project. Strong communication (written, oral) and project management skills. Able to handle multiple competing tasks with great attention to detail. Able to work independently to achieve objectives on or before schedule. Demonstrated cross-functional collaboration and teamwork skills including influencing without authority. Comprehensive knowledge of medical device regulations and standards. Current knowledge of European quality system standards, and requirements under EU MDR and IVDR preferred. Ability to navigate ambiguous regulatory requirements and standards interpretation.,

Job Title: MedTech Subject Matter Expert – Edge AI & Connectivity Platform Location: Remote (Global collaboration across US and India time zones) Some travel may be required for client workshops or audits Role Overview: We are seeking a highly experienced MedTech Subject Matter Expert (SME) to lead domain strategy, compliance alignment, and clinical relevance for a next-generation Edge AI & Connectivity Platform. This role is critical to ensuring that the solution aligns with healthcare regulatory requirements, clinical workflows, and emerging standards in connected diagnostics, real-time patient monitoring, and intelligent medical devices. The SME will interface between engineering teams and client stakeholders, ensuring the solution is clinically viable, regulatory compliant, and technically scalable. Key Responsibilities: Serve as the MedTech domain authority across platform design, development, and validation activities. Translate clinical, regulatory, and business requirements into platform architecture guidance, user needs, and technical features. Ensure end-to-end alignment with global MedTech standards including: FDA 510(k) submission requirements HIPAA and data privacy laws EU MDR and ISO 13485 QMS IEC 62304 for medical device software Review technical design documents, requirement specifications, and validation protocols to ensure regulatory readiness. Work with solution architects to validate use cases such as remote patient monitoring, connected diagnostics, and real-time health telemetry. Collaborate with product and engineering teams to define edge-to-cloud data flows, security models, and interoperability using HL7, FHIR, and DICOM standards. Lead compliance documentation for V&V (Verification & Validation), audit support, and risk management (ISO 14971). Participate in client-facing workshops, roadmap planning sessions, and technical presentations to drive stakeholder buy-in. Stay updated on innovations and trends in Digital Health, Real-time AI/ML in MedTech, Device Interoperability, and emerging FDA guidance. Required Qualifications and Experience: 10–18 years of experience in the Medical Device or Digital Health industry, preferably with exposure to edge, IoT, or AI-based solutions. Proven track record of working on regulated healthcare products (Class I, II, or III medical devices). Deep understanding of clinical workflows, device lifecycle management, and digital transformation within hospitals or diagnostics labs. Prior experience working on product submissions to FDA, CE, or other regulatory authorities. Strong grasp of software design controls, clinical risk management, usability engineering, and medical data privacy. Domain and Regulatory Expertise Required: Medical device software development lifecycle (IEC 62304) Quality management systems (ISO 13485) Risk management standards (ISO 14971) Data privacy & security regulations (HIPAA, GDPR) FDA regulatory pathways (e.g., 510(k), De Novo) EU MDR guidelines and documentation requirements Medical interoperability protocols: HL7, FHIR, DICOM Preferred Skills & Certifications: RAC Certification (Regulatory Affairs Certification) Certified HIPAA Professional (CHP) Biomedical Engineering, Clinical Informatics, or HealthTech Product Development background Experience working with cloud-to-edge data platforms (e.g., Azure IoT, GCP Edge, AWS Greengrass) Familiarity with cybersecurity for medical devices (e.g., FDA Pre-market Guidance for Cybersecurity) Stakeholder Engagement & Communication: Comfortable presenting complex regulatory and clinical content to technical and non-technical stakeholders. Prior experience leading workshops, requirement elicitation sessions, and technical steering committees. Ability to work closely with product managers, clinical advisors, embedded engineers, and cloud/AI architects. Strong documentation and writing skills for review of QMS documentation, SoPs, and V&V reports. Why Join This Project: You’ll be the face of MedTech strategy for a cutting-edge connected healthcare platform designed to reshape patient outcomes and real-time diagnostics. This is an opportunity to work at the intersection of regulatory science, clinical innovation, and applied AI backed by a global delivery team with strong engineering depth and execution maturity.