- Twist BioScience (South San Francisco, CA)
- …at multiple levels within all functional departments, including Quality Assurance, Regulatory Affairs , Supplier Quality, Supply Chain, Quality Control, ... Production, Process Development, Product Development, Software Development, R&D, Global Support in addition to building relationships with partners that manufacture… more
- 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
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, Regulatory Affairs , Device works with internal and external ... organizations. Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate,… more
- Oracle (Montpelier, VT)
- …success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration ... across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs. **Responsibilities** **Preferred… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …The Regulatory Affairs Specialist III is responsible for ensuring regulatory compliance and supporting global market access for in vitro diagnostic (IVD) ... the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working...for success in this position. To qualify for the Regulatory Affairs Specialist III role, candidates must… more
- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing ... variations) around small molecule drug substance, drug products and drug- device combination products. Ensure compliance with global ...local and/or global functional units [OPC CMC Global Regulatory Affairs , Global… more
- Olympus Corporation of the Americas (Westborough, MA)
- …technologies aligned with the Business Unit priority. + Interface with International Regulatory Affairs Team to ensure global planning considerations ... + Minimum of 10 years of Regulatory Affairs experience, ideally within the medical device ... Device . + Demonstrated leadership in managing the global submission process for regulatory approvals across… more
- Medtronic (Santa Rosa, CA)
- …+ Bachelor's degree required with a + Minimum of 4 years of experience in medical device regulatory affairs experience + Or Advanced degree with 2 years of ... submissions and negotiates their approval with the agencies. The Sr Regulatory Affairs Specialist is responsible for assessment of device changes for … more