- Hologic (Marlborough, MA)
- …preferred. + A minimum of 8 years of experience in Regulatory Affairs within the Medical Device industry. + Experience authoring/supporting/maintaining ... Manager, Global Regulatory Affairs Marlborough, MA, United States...proficiency working within a QMS. + Firm understanding of regulatory challenges in the medical device… more
- Fresenius Medical Center (Lexington, MA)
- … or a closely related field and 5 years of experience as a Regulatory Affairs Specialist in the medical device field or (ii) a Master's degree (or ... Senior Regulatory Affairs Specialist, NxStage Medical...3 years of experience as a Regulatory Affairs Specialist in the medical device... Regulatory Affairs Specialist in the medical device field. Must also have 3… more
- Medtronic (Boston, MA)
- …5 years of relevant experience **Nice to Have: Preferred Qualifications** + 7+ years of medical device regulatory affairs with roles showing increasing ... world. **A Day in the Life** As a **Principal Regulatory Affairs Specialist** at Medtronic, you will...standards. + Apply in-depth knowledge of FDA regulations, EU Medical Device Directive (93/42/EEC), Medical … more
- Philips (Cambridge, MA)
- …of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with Software as Medical ... As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal ...Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally. + You're able to work in… more
- Philips (Cambridge, MA)
- …**You're the right fit if:** + You've acquired 5+ years of experience in the medical device regulatory affairs and/or quality assurance field. Experience ... **Senior Regulatory Affairs Specialist (Ultrasound)** The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory … more
- Sanofi Group (Cambridge, MA)
- …responsibilities. **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...+ Dealt effectively with cross-functional groups, which may include Medical , Legal, Marketing, etc. + Experience managing others is… more
- Danaher Corporation (Boston, MA)
- …(https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for ... pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead...on the development and registration activities for the respective medical products + Develop and manage regulatory … more
- Candela Corporation (Marlborough, MA)
- …RA topics required for both tactical and strategic initiatives. + Possess and exercise regulatory and medical device industry relationships to inform bold RA ... **Director, Global Regulatory Affairs ** Requisition Number **2872** Location...sciences/engineering/related field, plus 12 years of experience in the medical device industry with at least 10… more
- United Therapeutics (Boston, MA)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)**...experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of… more
- Sanofi Group (Cambridge, MA)
- …(3+ years preferred) of regulatory experience, preferably within the pharmaceutical/ medical device /biotech industry + Knowledge and understanding of complex ... **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location**...R&D colleagues, as well as other stakeholders (eg, Legal, Medical , Marketing, Communications and Compliance). + Participates in the… more