- Philips (Cambridge, MA)
- …on the preparation and submission of 510K's, PMA's and experience with EU MDR /MDD, Health Canada, China, etc. + You have a strong background in Design Controls. ... The Senior Regulatory Affairs Program Manager will play a critical role in ensuring...detailed knowledge of medical device regulations (21CFR), FDA law, MDD/ MDR , other global laws, regulations and standards… more
- Olympus Corporation of the Americas (Westborough, MA)
- …for reviewing and authoring all Customer Quality external audit responses prior to submission to corporate compliance and / or regulators. The position will ensure ... internal and external responses. + Reviews and authors responses prior to submission to Corporate Compliance and/or regulators + Tracks, trends, and analyzes audit… more
- ThermoFisher Scientific (Waltham, MA)
- …pharmaceutical services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational guidance and ... of regulatory compliance within LPE. Responsible for leading and developing the global RA team supporting LPE. Responsible for reviewing and providing guidance to… more
- Olympus Corporation of the Americas (Westborough, MA)
- …handling requests for additional information and other post market responses prior to submission to regulators. + Develops a global post market regulator ... requests for additional information from regulators ensuring communicationsadhere the Global Quality System and applicable regulatory requirements. + Responsible for… more