- Olympus Corporation of the Americas (Westborough, MA)
- …Minimum of 10 years of Regulatory Affairs experience, ideally within the medical device or digital health industries. + Minimum of 3 years focused on ... medical devices . This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies for digital… 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 ... to the digital transformation in the medical device space. The role focuses on executing regulatory...sensitivity to cultural differences. + Familiarity with digital health regulatory frameworks for medical 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. + ... solutions, including Artificial Intelligence (AI) exempt from the medical device classification, and connected technologies. + Provide regulatory guidance,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …subject matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC, ... projects as required by the SDLC and will support Regulatory Affairs ' efforts in creating submission materials...on regulations around health software development, and software for medical devices . + Collaborate on the update… more
- Olympus Corporation of the Americas (Westborough, MA)
- …21 CFR 820 and ISO 13485 required. + Working knowledge of international medical device quality system requirements required. + Complete understanding and ... and early morning teleconferences. **Preferred:** + MBA Preferred. + Medical Device Experience preferred + Black Belt...Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs … 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...Regulatory Affairs students with interest in medical devices . + Strong research, writing, and… 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 (Framingham, MA)
- …teams + Develop and execute innovative and sustainable medical device regulatory strategies covering stand-alone medical devices and device part ... **Job title** : Global Regulatory Affairs Device Lead...to internal regulatory processes and procedures for medical devices + Accountable for regulatory… 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 ... regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This...+ Experience with software as a medical device , AI and/or medical devices … more
