- Oracle (Boston, MA)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… more
- Sanofi Group (Cambridge, MA)
- …Sciences or other relevant discipline + 8+ years of experience within pharmaceutical or medical device Regulatory Affairs , with 5+ years specifically ... **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion...without relying on authority, including participating in cross-functional groups ( medical , legal, regulatory , etc.) to lead toward… more
- Avania (Boston, MA)
- …are Hiring - Regulatory & Market Access Interns x2 We are seeking two, part-time Medical Device Regulatory Affairs & Quality Interns to join the ... efforts. + Content Development + Contribute to creation of medical device regulatory and quality-focused...Northeastern University Master of Science in Regulatory Affairs students with interest in medical devices.… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team...Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across… more
- Evident Scientific (Needham, MA)
- … (US Focus)** + Act as US regulatory lead for clinical and medical device products, overseeing FDA submissions (510(k), PMA) and communications. + Ensure ... Biomedical Engineering, or related field. + 7-10 years' experience in Regulatory or Clinical Affairs ( medical devices/IVD). + Hands-on experience with FDA… more
- Medtronic (Boston, MA)
- …Have: Minimum Requirements** + Bachelors degree with 4+ years of regulatory affairs experience in the medical device , biotech or pharmaceutical industry ... OR a Masters degree with 2+ years of regulatory affairs experience in the medical device , biotech or pharmaceutical industry. **Nice to Have** +… more
- Philips (Cambridge, MA)
- …if:** + You've acquired a minimum of 7+ years' experience in Regulatory Affairs /Strategy within FDA regulated Medical Device environments. + You have ... The Principal Regulatory Affairs Specialist will develop and...The Principal Regulatory Affairs Specialist will develop and execute the ...corrections, with a primary focus on Software as a Medical Device (SaMD) for our Sleep &… more
- Bausch + Lomb (Boston, MA)
- …+ Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device , cosmetics or ... and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative...**We offer competitive salary & excellent benefits including:** + Medical , Dental, Eye Health, Disability and Life Insurance begins… more
- Bristol Myers Squibb (Cambridge, MA)
- …more: careers.bms.com/working-with-us . **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for ... Solid scientific background, PhD., MD, PharmD, MS + Significant experience in regulatory affairs and diagnostic-related development eg, >8-10 years. + Scientific… more
- IQVIA (Boston, MA)
- …data, etc.), HCP engagement by life sciences companies. Expertise in domains adjacent to medical affairs , such as regulatory or pharmacovigilance, would also ... **Manager, Medical Affairs Strategy** **Overview** IQVIA is...diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies as well… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Medical Affairs Director - Oncology **Location:** Cambridge, MA / Morristown, NJ **About the job** **About us:** In order to pursue ... miracles of science to improve people's lives", Specialty Care Medical Affairs have a vision to be...engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs … more
- Fujifilm (Boston, MA)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- Sanofi Group (Cambridge, MA)
- …strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle. ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team...teams. + Contribute to and execute innovative and sustainable medical device regulatory strategies covering… more
- Pfizer (Cambridge, MA)
- …industry, preferably in Drug Development or Clinical Research, ideally within Regulatory Affairs + Subject-matter expertise within assigned therapeutic area ... to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Regulatory Affairs more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… more
- Edwards Lifesciences (Boston, MA)
- …Bachelor's Degree in a related field with 5 years of related experience working in medical affairs , clinical affairs and/or clinical science **What else we ... internal/external working relationships + The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment… more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , ... the Company-wide patient safety expert for assigned pharmaceutical / biological / drug- device combined products, accountable for the safety strategy and major safety… more
- Kelly Services (Raynham, MA)
- …in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common ... The CER Technical Writer must have experience within the medical device industry and knowledge of clinical...Directors, Post Market Surveillance, Design Quality Engineers, R&D, Clinical Affairs and Regulatory Affairs relating… more
- Astrix Technology (Boston, MA)
- …Work closely with internal teams such as Clinical Development, Regulatory Affairs , and Commercial to provide medical insights that inform strategic ... medical affairs role within the pharmaceutical, biotechnology, or medical device industry. + Scientific Expertise: Deep understanding of therapeutic… more
- Philips (Cambridge, MA)
- …the right fit if:** + You have a minimum of 15+ years' combined experience in Medical Device Clinical Research and Medical Device development within FDA ... Japan and China. + You have a detailed understanding of Clinical & Medical Affairs , leveraging expertise to propose innovative ideas, providing meaningful input… more