55 Eu Mdr Jobs

Role Objective Key objective of this role is to prepare, review, and maintain regulatory documents in compliance with international standards and country-specific requirements. The role ensures timely preparation and updating of Technical Master Files, supports product registrations, manages post-market surveillance activities, and contributes to audit readiness. This position requires close collaboration with internal stakeholders to ensure consistent regulatory compliance across the organization. Desired Candidate Profile Graduate/Postgraduate in Pharmacy, Biotechnology, Life Sciences, or a related discipline. 69 years of experience in Regulatory Affairs, preferably in the pharmaceutical, ...

Role : Design Quality SME Location : Pune Experience: 8+ Years Working days : 5 days work form Office. Degree in mechanical engineering,electrical engineering,applied sciences or a related discipline; 8+ years of professional experience in medical device regulatory Quality systems EU MDR,US FDA 510(K)and closely working R&D,Regulatory Affairs organizations Strong proven experience in simplifying/reviewing DHFs,Design requirements,IFUs,Risk management,V&V activities etc . Expertise in interpreting &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 developm...

Job Title: New Product Development Trainer Location: Remote Job type: Part -time Job Summary: We are seeking an experienced NPD Trainer with over a decade of hands-on expertise in medical device design, product development, validation, and regulatory compliance . The Trainer will be responsible for designing and delivering structured training programs to upskill engineers, technicians, and project managers in end-to-end new product development processes from concept to commercialization. The ideal candidate should possess strong technical depth, familiarity with ISO 13485, FDA 21 CFR Part 820, and Design Control requirements, and the ability to translate complex product development concepts ...

Key Responsibilities • Regulatory Compliance Management (Core Focus): Act as the internal expert, ensuring product compliance with current and upcoming global regulations, including but not limited to REACH, RoHS, Prop 65, TSCA, PFAS, POP, and EU MDR. • Customer & Supplier Liaison: Serve as the primary point of contact for compliance matters, effectively communicating requirements to suppliers and providing clear, accurate compliance information to customers. • Report Preparation & Documentation: Develop, maintain, and present detailed compliance reports, declarations, and technical documentation for internal stakeholders and regulatory bodies. • Process Improvement & Tool Utilization: Proac...

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that's bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it We understand that you are looking for growth in your caree...

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 Role Summary The QARA Director for India will be responsible for leading a team supporting Quality Assurance and Regulatory Affairs activities in India. This leadership role is responsible for developing and executing regulatory strategies and maintaining quality related activities and systems to ensure compliance with Indian and international medical device regulations (e.g. CDSCO, ISO 13485/Indian GMP, US FDA, EU MDR). The QA/RA Dire...

Job Description Summary Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area. Job Description Roles and Responsibilities Creates a Quality culture by driving compliance activities around a specific product, site or region. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Broadening knowledge of theories, practices and procedures in own discipline to...

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Responsibilities may include the following and other duties may be assigned. Lead and mentor cross-functional teams to develop comprehensive signal evaluation reports, product risk management files including risk management plans, Hazard Analysis, DFMEA, and risk management reports, adhering to ISO 14971 standards. Oversee the preparation and compilation of product post-market data and findings into comprehensive Periodic Safety Update...

Roles And Responsibilities Lead and manage CAPA process from initiation to closure. Coordinate root cause investigations and ensure robust corrective actions. Track and report CAPA metrics and trends to management. Drive quality improvement projects and cross-functional collaboration. Ensure timely documentation and regulatory compliance. Facilitate audits and provide CAPA-related evidence. Support risk management and preventive action initiatives. Qualifications Bachelor's degree in Engineering, Mechanical or related field. 7+ years experience in Quality/Regulatory in the medical device industry. Strong knowledge of ISO 13485, 21 CFR 820, EU MDR, and risk management (ISO 14971). Project man...

Job Title Design Quality Engineer - Medical Devices Job Description The Design Quality Engineer DQE provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met. The DQE also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes Your Role Ensure appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design Validate key design inputs like usability, reliability, performance, supportability, manufacturability, localizability...

Why join AliveCor ? At AliveCor, we imagine a healthier world powered by access to personalised intelligent information. Were on a mission to be the world s heart health partner by enabling access to quality heart care for everyone. AliveCor has pioneered over-the-counter medical ECG devices and continues to lead the way in empowering consumers and patients to take care of their heart. Using our FDA-cleared medical-grade hardware and software, millions of users have taken more than 200 million heart health measurements and counting. Our vibrant team of people are attracted to AliveCor because they want to build something meaningful -- and AliveCor delivers: every day, customers tell us that ...

Opportunity to work with a global medical equipment company Opportunity to take on a leadership role and contribute to the company's vision About Our Client Our client is a leading global medical technology company that provides innovative solutions in diagnostic and therapeutic imaging, laboratory diagnostics, and digital health services. Job Description The Successful Applicant Regulatory Strategy Development Define and drive the regulatory vision and strategy for CRM products, aligning with Healthineers business goals. Establish a roadmap for regulatory submissions, approvals, and compliance for new and existing product lines. Lead initiatives to address regulatory challenges in emerging ...

Job Title: QMS Specialist # Salary: As per Industry Standards (Depend on Experience/Knowledge) # Job Summary: We are seeking a highly skilled and experienced QMS Specialist to join our team in the plastic molding industry. The successful candidate will be responsible for implementing, maintaining, and continuously improving our QMS, ensuring compliance with international standards and regulations. # Key Responsibilities: 1. Develop, implement, and maintain QMS in accordance with international standards (e.g., ISO 9001, IATF 16949). 2. Ensure compliance with regulatory requirements, industry standards, and customer-specific requirements. 3. Conduct internal audits to ensure the effectiveness ...

Job Title: QMS Specialist # Salary: As per Industry Standards (Depend on Experience/Knowledge) # Job Summary: We are seeking a highly skilled and experienced QMS Specialist to join our team in the plastic molding industry. The successful candidate will be responsible for implementing, maintaining, and continuously improving our QMS, ensuring compliance with international standards and regulations. # Key Responsibilities: 1. Develop, implement, and maintain QMS in accordance with international standards (e.g., ISO 9001, IATF 16949). 2. Ensure compliance with regulatory requirements, industry standards, and customer-specific requirements. 3. Conduct internal audits to ensure the effectiveness ...

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 itu2019s not just what we do, itu2019s who we are. We are 80,000, wonderfully unique individuals, with two things in common. and a relentless determination to deliver on our customersu2019 needs. Itu2019s what inspires us to create meaningful solutions u2013 the kind that make a real difference u2013 when it matters most. The world and our customersu2019 needs are changing faster than ever before and while we are proud of what we do already, we know w...

Key Responsibilities: Lead preparation and implementation of ISO 13485, MDSAP, and 21 CFR Part 820 compliance. Manage the preparation of the Design Dossier along with other documents and ensure compliance with EU MDR requirements. Conduct gap analysis of client QMS and MDD/MDR documentation. Draft, review, and approve stability study protocols, reports, and validation documentation. Organise and oversee Internal Quality Audits (IQA) and Management Review Meetings (MRMs). Plan and execute predefined visits based on client needs and predetermined agendas. Conduct internal audits of systems and processes to identify non-conformances and drive closure. Update technical documentation (CER, PSUR, ...

Role Overview: You will be responsible for utilizing your expertise in Medical Electronics Design & Consulting to contribute to the introduction of Medical Technology. With over 10 years of experience in the field, you will play a crucial role in the complete Medical electronic devices/equipment/product Design Lifecycle, covering aspects such as Value Discovery, architecting, Design, and Testing. Your exposure will extend to current architectures like Internet of Medical Things (IoMT), Microservices/SoA, AI enabled therapeutics/diagnostics/medical imaging/personalized medicine/prognostics/telemedicine, SaMD, Digital healthcare/surgical platforms, etc. Furthermore, your knowledge of Robotics ...

Gentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life. Our success is a result of the talents, dedication and commitment of our people to drive our business forward. We provide career advancement opportunities through Gentell University, leadership development programs and executive mentoring. You would be joining a company committed to make it better every day, for our customers and for our employees. The Regulatory Affairs...

Role Overview: As part of the dynamic and experienced team at HARMAN Digital Transformation Solutions (DTS), you will be working on innovative projects that combine physical and digital technologies to create solutions for healthcare and MedTech industries. Your role as an Engineering Manager for Healthcare Projects will involve leading and managing large-scale projects, ensuring alignment with business goals, regulatory standards, and collaborating with cross-functional teams. Key Responsibilities: - Lead the successful delivery of complex healthcare and MedTech projects, ensuring alignment with business goals, timelines, and regulatory standards. - Manage and mentor a large, cross-function...

Key Deliverables : Plan and conduct audits in compliance with ISO 13485, EU MDR, and MDSAP standards. Review and evaluate technical files and documentation for medical devices. Collaborate with audit teams to ensure quality, compliance, and client satisfaction. Support certification decisions and regulatory reviews as per DNV and accreditation guidelines. Role Responsibilities : Execute audits independently and manage auditing teams when needed. Maintain audit documentation and timely delivery of reports. Ensure adherence to global regulatory and accreditation standards. Engage with clients and internal stakeholders to support quality assurance.

We are seeking an experienced Supplier Quality Professional Trainer with 10+ years of expertise in managing supplier quality assurance , supplier development, and compliance in regulated industries (pharmaceutical, biotech, or medical devices). The role involves ensuring suppliers meet company , industry, and regulatory standards by leading audits, driving quality improvement initiatives , and building strong supplier partnerships. Job Responsibilities: Develop and manage supplier quality strategies, policies, and risk management processes. Lead supplier qualification, selection, and approval in alignment with regulatory standards (FDA, EMA, ISO 13485, ICH Q10, GMP). Conduct supplier audits,...

You will be joining Kaushik Orthopaedic as a Senior Product Development Engineer, specializing in New Product Development. With our headquarters in Delhi-NCR and a strong global presence across markets in EMEA, South East Asia, and Latin America, we have been a leading Orthopaedic Device Manufacturer since 1989. As a qualified candidate, you should hold a Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related field. You must have a minimum of 5+ years of experience in designing and developing medical devices, particularly orthopaedic implants and instruments. Your expertise should encompass design principles, biomechanics, and materials science. Profici...

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 Job Description We are looking for a skilled & driven Product Owner with a strong technical background and experience in the healthcare domain. The ideal candidate will lead the product /platform development efforts, ensuring ...

Position Title: Regulatory Affairs & QA Manager Department: Quality & Regulatory Affairs Location: Bangalore Role Overview The Regulatory Affairs cum QA Manager will be responsible for ensuring compliance of medical devices with applicable international and local regulatory requirements, while also leading the Quality Management System (QMS) to meet ISO 13485, MDR, US FDA, and other relevant standards. This role is critical in bridging product development, regulatory submissions, audits, and market access, ensuring patient safety and product quality at all times. Key Responsibilities Regulatory Affairs: Develop and implement regulatory strategies for product registration, approvals, and cert...

Job Title Software Quality Engineer Job Description Job title: Software Quality Engineer Your role: Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design. Validates key design inputs (i.e. usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs). Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle. Can lead quality related problem solving for software. Use post-market analytics and statistics ...