- Medtronic (Mansfield, MA)
- …in a more connected, compassionate world. **A Day in the Life** We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute ... in regulatory affairs **Nice to Have** + 4+ years of medical device regulatory affairs experience + Local to CO and willing to work hybrid for… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, … more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as GRA ... and other unique modalities + Represents, contributes and influences Regulatory , Pharmaceutical Development, and Commercial project teams throughout clinical… more
- Hologic (Marlborough, MA)
- …biomedical engineering with a minimum of 8-10 years direct experience in Regulatory Affairs within the IVD or medical device industries. + Master's Degree in ... internal stakeholders. + Consults with and provides advice to senior management on strategies and plans for regulatory...of 5-8 years direct experience in Regulatory Affairs within the IVD or medical device… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …brand objectives. Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs , Market Access, Legal, Clinical) to help anticipate, ... We are seeking a Senior Director, Federal Government Affairs to...for in a multitude of public policy, legislative, and regulatory regimes and initiatives. Key Responsibilities Serve as the… more
- Fresenius Medical Center (Waltham, MA)
- …MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership in medical /clinical development, commercial, and other functional areas ... (Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you...Advisor and function as the "R" in the core Medical , Legal, and Regulatory review functions within… more
- Evident Scientific (Waltham, MA)
- Executive Director, Regulatory Affairs & Quality Assurance. Job ID #: 2023 Company: Evident Posting Date: Jun 3, 2025 **Working Location:** **MASSACHUSETTS, ... inspire healthier lives, together.** **Job Description** The Executive Director, Quality and Regulatory Affairs (Exec Dir QARA), will oversee the Quality, … more
- Takeda Pharmaceuticals (Boston, MA)
- …and tracking of required actions until completion + Monitor progress toward Global Regulatory Affairs KPIs, intervening as necessary to ensure that Regulatory ... experience in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical supplies + Experience in R&D operations… 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...In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues… more