- 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
- 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …leastfive years experience in Quality Systems/Auditing function, preferably in medical device . + Expert knowledge of ISO13485, ISO14971, ( EU ) 2017/745, ( ... **Job Description** BD is one of the largest global medical technology companies in the world. Advancing the world...EU ) 2017/746, RDC 665/2022, TGA regulation 2002, 21 CFR 820 and SOR/98-282. + Proven… 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