- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the… more
- Sanofi Group (Morristown, NJ)
- …turn the impossible into possible for millions. **Our Team/ Overview:** The Global Regulatory Affairs (GRA) CMC & Device Organization serves as a ... **Job Title:** Head of Global Regulatory Affairs , CMC...Device teams to achieve the implementation of appropriate global regulatory strategies. Assures that, for major… more
- Sanofi Group (Morristown, NJ)
- …skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting ... pathways. The team is accountable for developing and implementing global regulatory strategies for device ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Stryker (Mahwah, NJ)
- …launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations, time zones ... **Senior Manager, Regulatory Affairs - Joint Replacement Division**...provide leadership and coordination of the Joint Replacement divisions' global regulatory strategies, submission preparation and approvals… more
- Pentax Medical (Montvale, NJ)
- …devices and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an established medical ... for Endoscopes and Speech, Voice and Swallowing devices, meet global regulatory standards. This role will collaborate...shaping the future of medical technology. Responsibilities of Senior Regulatory Affairs Specialist : + Coordinate with… more
- Meta (New York, NY)
- …discipline or equivalent work experience 6. 6+ years of industry experience in medical device regulatory affairs or related industry 7. Experience working ... **Summary:** We're seeking a regulatory affairs specialist to join our...to work on wearables and Software as a Medical Device (SaMD) applications for the US and worldwide approvals.You… more
- Sanofi Group (Morristown, NJ)
- …other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically within advertising ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …the core team, aiding product development, remediation projects, and meeting medical device regulatory needs. + Review, comprehend, and compose performance and ... role in crafting the future of medical technology and making a tangible impact on global health. **Responsibilities:** + Present the medical affairs role within… more
- IQVIA (Parsippany, NJ)
- **Manager, Medical Affairs Strategy** **Overview** IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services ... of innovative medical treatments. Our diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …510(k), Q-Sub), EU technical documentation under MDR, and other global regulatory filings. + Evaluate medical device regulations and lead the development ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist will represent...change control, ensuring compliance with US, EU, and other global regulatory requirements. + Author FDA submissions… more
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