- 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 (Framingham, MA)
- …we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves ... **Job Title:** Global Regulatory Affairs CMC...**Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham,...GRA CMC Lead within our GRA CMC & GRA Device Organization, you'll drive global regulatory… more
- Sanofi Group (Cambridge, MA)
- …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 (Oklahoma City, OK)
- …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
- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Regulatory Affairs Diagnostics. This position is a hybrid ... candidates from any location to apply. The Associate Director, Global Regulatory Affairs Diagnostics will...submission of investigational and new in vitro diagnostic medical device applications to the regulatory authorities. This… 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
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …relevant experience. + Master's Degree (10+ years), Preferred + RAC ( Regulatory Affairs Certification) a plus. + Medical Device Industry preferred - will ... and impact of changes and support international counterparts in global regulatory submissions/approval. + Prepare, coordinate, and... affairs . + 3+ years of related regulatory submission experience from a medical device … 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
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Strategic Global Labeling Manager in Regulatory Affairs is responsible ... for assigned products. Product portfolio will include pharma, OTC, and/or device or combination products. + Lead cross-functional labeling teams to develop… more
- Olympus Corporation of the Americas (Westborough, MA)
- …in engineering or life sciences required. + Minimum of 7 years prior regulatory affairs experience in the medical device industry, or a minimum of 5 years ... more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports … more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …development and change control to ensure US, EU, and other global regulatory requirements are met + Evaluates medical device regulations and leads ... degree or higher + 6-8 years' Regulatory Affairs experience in the medical device industry...other regulatory colleagues + Comprehensive understanding of global medical device regulations, with in-depth knowledge… more
- West Pharmaceutical Services (Exton, PA)
- …to ensure timely approvals for market release and file maintenance + Works with global Regulatory Affairs colleagues, Quality Assurance and Research & ... Sr. Specialist Regulatory Affairs , MD Requisition ID: 71773...**Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's Transfer Devices… more
- Olympus Corporation of the Americas (Westborough, MA)
- …BS or comparable required. + Minimum of 10 years' experience in Regulatory Affairs , ideally within the medical device or digital health industries. + Minimum ... of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will… more
- GRAIL (Olympia, WA)
- …with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For...IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device … more
- J&J Family of Companies (Raynham, MA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... We are searching for the best talent for a ** Regulatory Affairs Specialist II** to support our...Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are **required** .… more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... We are searching for the best talent for a ** Regulatory Affairs Specialist II** to support our...Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are **required** .… more
- embecta (Parsippany, NJ)
- …or technical discipline (eg engineering, bioengineering, biology, chemistry). + 5+ years Regulatory Affairs experience in medical device companies. + ... devices in both the US and Europe, and related regulatory affairs activities to ensure compliance with...Experience negotiating with Health Authority personnel in the medical device area. + Demonstrated global perspective, customer… more
- Philips (Plymouth, MN)
- **Intern - Regulatory Affairs - Minneapolis, MN - Summer 2026** We welcome individuals who are currently pursuing an undergraduate degree in engineering to join ... Philips as a Regulatory Affairs Intern in our Minneapolis location...a science related field. + General knowledge of medical device regulations (21CFR), FDA law, MDD, other global… more