- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...teams + Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices … more
- Amgen (Cambridge, MA)
- …team. Join us and transform the lives of patients while transforming your career. ** Director , Commercial Drug Products & Life Cycle Management** **What you will ... of non-conformance investigations and change control assessments to ensure supply of commercial drug products. We are seeking a director to lead an impactful… more
- Olympus Corporation of the Americas (Westborough, MA)
- …the FDA 2016 Guidance, 'Applying Human Factors and Usability Engineering to Medical Devices Guidance for Industry and Food and Drug Administration Staff ', ... a mentor and hands-on multi-disciplinary technical leader with a strong medical device background and excellent communication skills. This position leads the US… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Readiness, and Innovation needs working closely with each PharmSci R&D function ( Drug Product & Device Development, Analytical Development, Biologics Process ... Masters Degree preferred. + Minimum of 10-15 years relevant clinical/commercial drug , device , and/or combination product Pharmaceutical experience This position… more
- GRAIL (Boston, MA)
- …position supports the US Regulatory team in preparing Investigational Device Exemptions (IDEs), IDE supplements, pre-submissions, Premarket Approvals (PMAs), annual ... 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings. + Serve as a key member of the Regulatory… more
- Bristol Myers Squibb (Cambridge, MA)
- …member of the Translational Medicine CLIA Laboratory Steering Committee, the director drives coordinated early-stage drug -diagnostic strategies and health ... paired with deep expertise in developing and executing global regulatory strategies across drug and device development. + Regulatory Standards Mastery, but not… more
- Abbott (Boston, MA)
- …of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 colleagues serve people ... products for treatment of vascular disease. Our extensive portfolio includes drug -eluting stents, guide wires, balloon dilatation catheters, imaging catheters and… more
- Hologic (Marlborough, MA)
- …regional health plans in the US, ideally with a background in medical device , drug , radiopharmaceuticals, radiology or breast surgery. Candidates should possess ... Director , Payer Relations Marlborough, MA, United States As...with and managing external vendors + Preferred knowledge of drug - device combination products, radiopharmaceuticals, and innovative payment… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory ... understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge of the Drug Discovery, PharmSci CMC functional areas including drug devices and its supporting technologies + Operational knowledge of emerging ... digital and technology strategy for Pharm Sci biotherapeutics and synthetic molecule drug and device development and clinical manufacturing through shared… more