- Kelly Services (Bridgewater, NJ)
- ** EU - Medical Device Regulation (MDR) Specialist** Kelly(R) Science & Clinical is seeking an ** EU -MDR Specialist** for our client in Bridgewater, NJ. ... 2025 may extend into 2026 **Responsibilities:** + Contribute to the implementation of EU - Medical Device Regulation (MDR) and global regulation … more
- Terumo Medical Corporation (Somerset, NJ)
- …standards such as FDA Quality System Regulation , 21 CFR Part 820, ISO 13485:2016, EU Medical Device Regulation , etc. 3. Drive engagement to ensure ... of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in...applicable global regulations (21 CFR Part 820, ISO 13485:2016, EU MDR etc. S/he will be responsible for directing… more
- Integra LifeSciences (Princeton, NJ)
- …regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation , Japanese Pharmaceutical Affairs Law, ... + Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC),...standards. + Experience with direct contact with FDA and EU Notified Bodies. + Knowledge of process design and… more
- Integra LifeSciences (Princeton, NJ)
- …regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation , Japanese Pharmaceutical Affairs Law, ... + Demonstrated knowledge of FDA regulations, ISO 13485, CMDR, Medical Device Directive Regulation (93/42EEC),...standards. + Experience with direct contact with FDA and EU Notified Bodies. + Knowledge of process design and… more
- Integra LifeSciences (Princeton, NJ)
- …regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation , Japanese Pharmaceutical Affairs Law, ... 14 manufacturing facilities and a diverse portfolio of leading medical devices. This role is crucial for ensuring the...appropriate regulations and standards, including FDA, ISO 13485, CMDR, EU MDR and JPAL. + Interact and coordinate activities… more
- Terumo Medical Corporation (Somerset, NJ)
- …14971, ISO 11607, ISO 11135/ EN550, ISO 11137/ EN552 and the amended Medical Device Directive). + Assist with third party/regulatory audits (Customer, Notified ... 5, 2024 Req ID: 3503 Location: Somerset, NJ, US Company: Terumo Medical Corporation Department: Quality Systems & Compliance **Job Summary** The Quality Compliance… more
- Kelly Services (Plainsboro, NJ)
- …of 3+ years of experience in manufacturing engineering within the medical device industry + Experience with Quality System Regulation (QSR), Design Control ... provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct Non-Conformance… more
- J&J Family of Companies (Raritan, NJ)
- …Johnson& Johnson, procedures and guidelines, this position: + Learns the details of medical device risk management and perform Application & Design Failure Mode ... products program in compliance with 21CFR part 4 (FDA Regulation for combination products). + Assists in various lifecycle...remediation activities, and integration of regulations, such as the EU MDR, into the business. + Supports the Franchise… more