- Fresenius Medical Center (Lexington, MA)
- …applicable regulations. * Maintains corporate regulatory files including EU technical files/documentation ( Medical Device Directives & Medical Device ... of experience as a Regulatory Affairs Specialist in the medical device field or (ii) a Master's...EU Notified Body submissions; * Working with ISO13485 and FDA Quality Management System requirements (QSR); *… more
- J&J Family of Companies (Raynham, MA)
- …, Engineering or R&D with significant leadership experience in a regulated industry ( medical device , pharmaceuticals, or similar) + 5+ years of experience in ... learning, and innovation focused on customer-centric quality . + Ensure all quality activities comply with regulatory standards (eg, FDA , ISO) and internal… more
- Teleflex (Chelmsford, MA)
- Quality Engineer II (Manufacturing) **Date:** Aug 13, 2025 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** ... :12403 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to...driven by our purpose to improve the health and quality of people's lives. Through our vision to become… more
- Philips (Cambridge, MA)
- …+ You have a minimum of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with Software ... as Medical Device (SaMD) and Ultrasound Imaging Devices highly desired. + You have strong knowledge of US FDA , China NMPA, CE Marking, EU MDD/MDR, JPAL,… more
- Boston University (Boston, MA)
- …assurance monitoring and auditing on human research studies conducted at BMC and BU Medical Campus. The Human Research Quality Manager will evaluate and verify ... **HUMAN RESEARCH QUALITY MANAGER, School of Medicine, Clinical Research** **Job...MANAGER, School of Medicine, Clinical Research** **Category** Boston University Medical Campus --> Professional **Job Location** Boston, MA, United… more
- Hologic (Marlborough, MA)
- …Supplier Quality Engineering roles. + 5+ years of experience in medical device manufacturing or related industries. + Hands-on experience with manufacturing ... understanding of regulatory standards like ISO-13485, ISO-14971, ISO-9001, CFR 820, and FDA requirements. + Familiarity with Quality Management Systems (QMS) and… more
- Sanofi Group (Cambridge, MA)
- …year (3+ years preferred) of regulatory experience, preferably within the pharmaceutical/ medical device /biotech industry + Knowledge and understanding of complex ... and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion… more
- Zimmer Biomet (Braintree, MA)
- …Site Quality programs to ensure compliance to domestic and international medical device regulations. **How You'll Create Impact** + Develop and facilitate ... innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's...processes, procedures and instruction to sustain and improve the Quality Management System. + Support Top Management in the… more
- Cardinal Health (Mansfield, MA)
- …Services Center perform laboratory testing to characterize the chemistries of our medical device products and stability testing for pharmaceutical products of ... manufacturing or testing environment, preferred. + Strong knowledge of ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other… more
- Fujifilm (Boston, MA)
- …and advertising regulations and other regulations specific to Life Sciences/Pharma and Medical Device companies. + Perform other duties as assigned. **Required ... corporate law firm and/or in-house legal department, preferably in the Life Sciences/Pharma, Medical Device or health care field. + Solid commercial contract… more