- CSL Behring (Waltham, MA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, ... business insights / analytics and other specialized regulatory functions (eg, device /combination products) to deliver Global Regulatory Strategy Outlines… more
- 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)
- …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...guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle.… 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
- Sanofi Group (Framingham, MA)
- …Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global Research and ... Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800... global healthcare industry. + Proven experience in drug/ device combination product regulatory approvals. + Demonstrate… more
- Dentsply Sirona (Waltham, MA)
- …Years and Type of Experience: + 5(+) years of experience in regulatory affairs , preferably in the medical device industry. + Experience with leading ... care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA....+ Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited… 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
- ThermoFisher Scientific (Waltham, MA)
- …or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting and ... Day in the Life:** + Interpret and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical… 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
- Bristol Myers Squibb (Devens, MA)
- …in pharmaceutical (medical device , biologics) facilities. + In-depth knowledge of global regulatory requirements (FDA, EMA, PMDA, etc.) and GxP standards. + ... agency inspections (eg, FDA, EMA, PMDA, etc.) across global pharmaceutical, biotech, cell therapy, and medical device...fields, required. + 10+ years of relevant experience in regulatory affairs , compliance, or quality assurance in… 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
