- Cole-Parmer (Franklin, MA)
- …field. Experience: + Experience in high volume manufacturing environment, preferably in medical devices or in-vitro diagnostics + Experience with European IVDD ... Job Title: Sr. Manager, Quality and Regulatory Assurance Reports To:...Benefits coverage begins day 1, including the following: + Medical , Dental, Vision Insurance + Disability Insurance + Life… 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
- Grifols Shared Services North America, Inc (Worcester, MA)
- … submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams ... regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products + Provides … 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** : Cambridge,...R&D colleagues, as well as other stakeholders (eg, Legal, Medical , Marketing, Communications and Compliance). + Participates in the… more
- J&J Family of Companies (Danvers, MA)
- …+ BA/BS or equivalent is required, with 8-10 years of proven experience in medical Device . + Excellent communication skills, able to quickly build credibility ... will be a member of the Abiomed and J&J Regulatory Compliance teams, will work with Quality ...participate in the following Company sponsored employee benefit programs: medical , dental, vision, life insurance, short- and long-term disability,… more
- Philips (Cambridge, MA)
- …fit if:** + You've acquired 5+ years of experience in the medical device regulatory affairs and/or quality assurance field. Experience authoring SaMD or ... **Senior Regulatory Affairs Specialist (Ultrasound)** The Senior Regulatory...Tech Files required. + Your skills include knowledge of quality system requirements and FDA and/or International product approval… more
- United Therapeutics (Boston, MA)
- …of biologic 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 ... ( **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… more
- Takeda Pharmaceuticals (Boston, MA)
- …regulatory nuances and requirements. + Understanding of scientific principles and regulatory / quality systems relevant to drug development. + Ability to ... bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development… 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
- Takeda Pharmaceuticals (Boston, MA)
- … nuances and requirements. + Basic knowledge of scientific principles and regulatory / quality systems relevant to drug development. + Ability to co-author, ... life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development… more