- Sanofi Group (Framingham, MA)
- **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 (Framingham, 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
- Parexel (Providence, RI)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... device combination products are a plus) * Support regulatory leads in developing contingency plans for CMC-related scenarios... Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global … more
- Olympus Corporation of the Americas (Westborough, MA)
- …Learn more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a ... (peer-to-peer) as well as societal engagement. + Clinical Research: To support the Global Head of Clinical Affairs in the conception, development, and… more
- Bausch + Lomb (Providence, RI)
- …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work...Affairs . This position does not work with medical device , cosmetics or supplements and we will only be… more
- Eliassen Group (Providence, RI)
- …risk management, and communication across all stakeholders. * Coordinate with Regulatory Affairs to ensure documentation and submission readiness for ... **Project Manager, Med Device , R&D PMO, Design Changes** **Anywhere** **Type:** Contract...modifications and component exchange programs while navigating a complex, global matrix organization. The project has completed feasibility and… more
- Hologic (Marlborough, MA)
- …Services globally. You will collaborate with key stakeholders, including Regulatory Affairs , Quality Assurance, Supplier Quality Assurance, Engineering ... Solutions Analyst, Global IT Quality Solutions** to join our **Quality, Regulatory , and Product Life Cycle Management Systems Center of Excellence (COE)** . This… more
- Hologic (Marlborough, MA)
- …the highest quality. Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs , Program Management, Legal, Marketing, and Operations to ... leading major US and global clinical trials across multiple phases of medical device development. You'll ensure studies are executed on-time, on-budget, and with… more
- Candela Corporation (Marlborough, MA)
- …quality / regulatory / compliance. . Expert understanding of relevant global /regional medical device regulations and standards with particular emphasis on ... improvement actions related feedback. . Jointly accountable with Quality System (QS) and Regulatory Affairs (RA) Leadership for ensuring the QS is effectively… more
- Hologic (Marlborough, MA)
- …product lifecycle. As a subject matter expert, you will partner with R&D, Regulatory Affairs , and Manufacturing Engineering teams to embed quality and compliance ... planning, and requirements traceability. + Familiarity with Good Laboratory Practices and global regulatory requirements for medical devices. + Proficiency in… more
- Hologic (Marlborough, MA)
- …role in new product development, ensuring that design controls, risk management, and global regulatory compliance are maintained from concept to product launch. ... compliance. + Collaborative and team-oriented, building strong relationships across R&D, Regulatory Affairs , Manufacturing, and other key stakeholders. +… more