- Fujifilm (Boston, MA)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...other applicable laws. + Keep abreast of legislative and regulatory changes with respect to healthcare and other relevant… more
- Sanofi Group (Cambridge, MA)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... with 10 years regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory experience required. + At least 10… 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 **US -...sciences/engineering/related field, plus 12 years of experience in the medical device industry with at least 10… more
- Medtronic (Boston, MA)
- …of relevant experience **Nice to Have: Preferred Qualifications** + 7+ years of medical device regulatory affairs with roles showing increasing ... will play a critical role in shaping the global regulatory strategy for innovative medical technologies. You...standards. + Apply in-depth knowledge of FDA regulations, EU Medical Device Directive (93/42/EEC), Medical … more
- Hologic (Marlborough, MA)
- …science related field preferred. + A minimum of 8 years of experience in Regulatory Affairs within the Medical Device industry. + Experience ... + Demonstrated proficiency working within a QMS. + Firm understanding of regulatory challenges in the medical device or IVD space. + Solid computer skills in… more
- Philips (Cambridge, MA)
- …the right fit if:** + You've acquired 5+ years of experience in the medical device regulatory affairs and/or quality assurance field. Experience authoring ... **Senior Regulatory Affairs Specialist (Ultrasound)** The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and… more
- Sanofi Group (Cambridge, MA)
- …responsibilities. **About You** **Experience:** + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge,...+ Dealt effectively with cross-functional groups, which may include Medical , Legal, Marketing, etc. + Experience managing others is… more
- Fresenius Medical Center (Lexington, MA)
- …regulations. * Maintains corporate regulatory files including EU technical files/documentation ( Medical Device Directives & Medical Device ... 5 years of experience as a Regulatory Affairs Specialist in the medical device field or (ii) a Master's degree (or equivalent foreign degree) in … more
- Amgen (Cambridge, MA)
- …to automate model creation and post/processing. + Experience with combination products and device regulatory requirements, medical device development and ... variety of challenging problems associated with advanced material modelling, device design, characterization, verification, validation, manufacturing and tolerance analysis.… more
- US Tech Solutions (Tewksbury, MA)
- …quickly learn and adapt to new systems. + Customer facing, manufacturing and/or Quality/ Regulatory experience in medical device and/or clinical industries. + ... front line support for internal and external customers regarding quality and regulatory related inquiries and issues, and act as liaison between customers and… more