1249 Mdr Jobs - Page 34

2+ years of experience in medical device regulatory affairs EU MDR, US FDA 510(k) and closely working R&D, Quality organizations. Experience creating Technical Documentation and 510(k) preparation and receiving submission approval (EU, US, Canada etc.) Expertise in interpreting and implementing various medical device standards and guidance's, such as IEC 60601-1, ISO 14971-1, IEC 62366-1, ISO10993-1, and MEDDEV 2.7/4. Experience with systems for quality management, product development, and follow-up of procedures is an advantage. Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP, EU MDR, Risk Management etc.) Personality Characteristics Be able to handle ad-...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Science...

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-l...

Job Title: Senior Regulatory Affairs Team Lead – Medical Devices Location: Chennai, India Department: Regulatory Affairs Experience Required: Minimum 5 years Reports To: Head of Regulatory Affairs / Director of Quality & Regulatory Job Summary: We are seeking a highly skilled and experienced Senior Regulatory Affairs Team Lead to manage and lead our regulatory submissions and strategy for medical devices in India. The ideal candidate will have a deep understanding of the regulatory framework governed by CDSCO (Central Drugs Standard Control Organization) and proven experience in successfully obtaining approvals for medical devices. This role requires both strategic oversight and hands-on exe...

Duties and Responsibilities:  Responsible for strategic development, implementation, maintenance, and overall success of the company’s regulatory project approvals in different countries.  Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy.  Regulatory affairs strategy and coordination with Internal and external team for Asia, Africa, ANZ, Middle East, Europe and LATAM countries.  Coordinate with the Sales & Marketing team for business continuity and center of contact for all regulatory matters.  Global coordination for regulatory planning and execu...

Education: Bachelor’s degree in Mechanical , Automobile , or Polymer Science or Diploma in the same fields Experience: Minimum 10 years in quality control , preferably in rubber or rubber-to-metal bonded product industries Experience with railway component standards (RDSO, CLW, ICF, RCF) is highly desirable Core Responsibilities: Independent Quality Leadership Lead the quality control function independently— separate from daily production and testing Oversee product validation, failure analysis , and corrective action planning Quality Management System Ensure implementation and continual improvement of the QMS as per ISO 9001 , IRIS , RDSO Collaborate with Design & R&D for new product develo...

Education: Bachelor’s degree in Rubber Technology, Polymer Science, or Chemical Engineering or Diploma in the above fields Experience: 5+ years for degree holders 10+ years for diploma holders Experience in rubber product manufacturing (preferably for railway or automotive sectors) Technical Responsibilities: Apply expertise in rubber chemistry, compounding, and formulation design Operate and interpret results from key equipment: 1) Kneaders, mixing mills, hydraulic/injection presses 2) Rheometers (MDR/ODR), Mooney viscometers 3) TGA, DSC, FTIR analyzers Analyze and interpret: 1) Rheographs 2) Thermo-analytical curves 3) FTIR spectra and physical property charts Develop, optimize, and valida...

Location: Sanand, Ahmedabad Experience: 7+ years Global Markets: Asia, Africa, ANZ, Europe, Middle East, LATAM 🔧 Key Responsibilities: Lead global regulatory strategy, planning, and execution for product approvals Manage medical device registrations across multiple international markets Coordinate with cross-functional teams (Sales, Marketing, RA coordinators) Oversee post-approval changes, document control, and inspection readiness Ensure compliance with global standards: ISO 13485, MDSAP, EU MDR, 510(k), Indian MDR Maintain and update RA policies, labels, IFUs, translations, and marketing claims Train and lead a team of international RA professionals Act as point of contact for global regu...

Job Title : Regulatory Specialist (ISO, CE, BIS Certifications & Audits) Job Summary : A Regulatory Specialist focusing on ISO, CE, BIS certifications, and audits plays a critical role in ensuring that products, services, and processes adhere to international standards and regulatory requirements. This specialist works with cross-functional teams to facilitate the certification process, manage audits, and ensure ongoing compliance with certification bodies. They ensure that the company meets regulatory requirements, helping maintain or achieve certifications in various industries such as manufacturing, healthcare, electronics, and more. Key Responsibilities :1. ISO Certification Management :...

About Paytm Group: Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About the Role As a Product Manager for Card Acquiring , you will be responsible for building and scaling card-based payment products for our vast network of offline and online merchants. You will work closely with banks, networks (Visa, Mastercard, Rupay, American Express), and internal teams to deliver high-performance card processing...

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 Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. Capable of mentoring junior quality engineers in providing quality engineering support. Responsibilities may include the following and other duties may be assigned Review New Product Introduction (NPI) and Released Product Management (Released Products) docume...

About Paytm Group: Paytm is India's leading mobile payments and financial services distribution company. Pioneer of the mobile QR payments revolution in India, Paytm builds technologies that help small businesses with payments and commerce. Paytm’s mission is to serve half a billion Indians and bring them to the mainstream economy with the help of technology. About the Role As a Product Manager for Card Acquiring , you will be responsible for building and scaling card-based payment products for our vast network of offline and online merchants. You will work closely with banks, networks (Visa, Mastercard, Rupay, American Express), and internal teams to deliver high-performance card processing...

At Scybers, we’re seeking a sharp, vigilant, and dynamic Detection & Response Lead to join our Managed Detection and Response (MDR) team. Step into a pivotal role where every day brings new challenges, and your strategic decisions will have a significant impact on our clients’ security. Preference will be given to candidates who can join immediately or short notice. What you will do, Handle client engagements and work as the main point of contact for MDR projects Continuously improve client engagement and the quality of delivery to SOC customers. Implement standards and procedures for projects to ensure alerts are addressed with relevancy, accuracy and in a timely manner Define process and m...

Job Purpose: To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction. Key Responsibilities: Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system. Acknowledge receipt of complaints and communicate resolution timelines to complainants. Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements. Coordinate...

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-l...

Purpose of the Role The Senior Salesforce Administrator is responsible for supporting the overall maintenance of the Salesforce platform. Acting as a central point of orchestration for developers, support teams, as well as end users, the administrator provides critical day to day support for deployment, user setup, data, monitoring, troubleshooting, enhancing, automating, reporting, upgrading and training of the platform. The Admin will also act as a first level SME for the Complaint Handling Process within the Trackwise system Primary Duties and Responsibilities Own the end to end administration of the Salesforce Platform including user management, workflows, and basic validations. Deployme...

University degree level or equivalent through experience and professional certification. A minimum of 4-7 years in Security and Loss prevention role, law enforcement or security-related profession. Extensive and up to date knowledge of Shrink management and Data Analysis. Experience in managing or coordinating security investigations of complex nature. Knowledge of information security processes and systems. Experience in security auditing Amazon’s SLP team is seeking highly skilled and motivated person to help develop a and implement a world class security program for our first mile network which will ensure that our customers receive the items they purchase on time and at the best possible...

We are hiring stores executive , You will be assisting in daily management of overall material stores. Inward materials quantity checking & packing machine & other Items. Also Labelling the GRN Stickers Walk IN Below Address 07th Jul-25 to 9th Jul-25 Address Prognosys Medical System Pvt Ltd Survey No. 168/1, Machohalli, Dasanapura Hobli, Next to Vani Vidyalaya, Off Magadi Road, Bengaluru, Karnataka, 560091 Visit Us: https://prognosysmedical.com/ Or reach us Mobile : 8951092392 Email : hr@prognosysmedical.com JD · Preparation of GRN as per the requirements · Handling all job work items & send via DC to vendors · Handling stock items of C-ARM / MDR /Service · Monitoring and control of Issues &...

Job Description Job Overview: The Principal Structural Engineer is responsible for interpreting internal or external business issues and recommending best practices. They will be tasked with solving complex structural-related problems and will work independently with minimal guidance. The Principal Structural Engineer may be responsible for leading functional teams or projects and is regarded as a specialist in the field of structural engineering. As such, they must have in-depth expertise in structural engineering as well as broad knowledge of the structural discipline within the engineering function. Responsibilities Key Tasks and Responsibilities: Perform conceptual, FEED, and detailed an...

Close date: Sunday, 17 August 2025 Working pattern: Full time Contract Type: Permanent Location: Gurgaon (SEZ1) Department: 13 - 13 Security Description & Requirements: Bravura’s Commitment and Mission At Bravura Solutions, collaboration, diversity and excellence matter. We value your ideas, giving you room to be curious and innovate in an exciting, fast-paced, and flexible environment. We look for many different skills and abilities, as well as how you can add value to Bravura and our culture. As a Global FinTech market leader and ASX listed company, Bravura is a trusted partner to over 350 leading financial services clients, delivering wealth management technology and products. We invest s...

Your Tasks & Responsibilities: Plan and execute product risk management activities together with the project management in an agile development. Work with cross functional teams to identify and evaluate potential safety risks and develop risk mitigation measures for hazardous situations which could occur in the use of the medical devices, health software products and components. Track the implementation of mitigations in close collaboration with product development teams to ensure the effectiveness of the risk control measures. Analyze various industry and regulatory sources of information for potentially applicable risks. Participate in the development and review of the product design input...

Date: Jul 4, 2025 Location: Bar Lev, IL, 20156 Company: Dentsply Sirona, Inc Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Cha...

Job Summary: We are seeking a highly skilled and detail-oriented Senior Quality Assurance (QA) Specialist to join our team in a medical equipment manufacturing environment. The successful candidate will be responsible for ensuring compliance with applicable regulatory standards (FDA, ISO 13485, MDR, etc.), leading quality assurance activities across the product lifecycle, and supporting continuous improvement initiatives in both design and manufacturing processes. Key Responsibilities: Ensure compliance with FDA 21 CFR Part 820 , ISO 13485 , ISO 14971 , and EU MDR regulations. Lead and participate in internal, supplier, and regulatory audits. Develop, implement, and maintain QA procedures , ...

We are looking for a skilled and detail-oriented QA Executive to join our team. The candidate will be responsible for ensuring the quality and regulatory compliance of medical devices in line with EU MDR 2017/745 and Indian Medical Device Rules (IMDR). This role involves preparing, reviewing, and updating key technical and regulatory documentation and supporting post-market surveillance activities. Roles & Responsibilities Preparation, review, and updating of Technical Files as per EU MDR 2017/745 and Device Master Files (DMF) as per IMDR . Maintenance of General Safety and Performance Requirements (GSPR) documentation in compliance with applicable guidelines. Preparation of Risk Management ...

Position Title: Security Operations Engineer Reports To: Director of Security Operations Security Operations Engineer is a technical subject matter expert responsible for executing key functions of CDK’s Security Monitoring and Response strategy with an automation first mindset . This individual plays a key technical role in our Security Operations organization and enables effective incident response via automated workflow s and efficient threat detection content . Key Responsibilities : 1. Technical Leadership : Exemplify security principles and culture Develop, implement, and tune automation playbooks that enable incident response Effectively partner across security, technology, and busine...