- 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
- Cardinal Health (Boston, MA)
- …in related field or equivalent work experience, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**... and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory … 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
- GRAIL (Boston, MA)
- …, development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries is required. + Regulatory ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals is required.… 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
- 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 ... + Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited...13485, EU MDR). + Experience with software as a medical device , AI and/or medical … 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 ... Sr. Mgr., Regulatory Affairs (RA) & Clinical ...Sr. Mgr., Regulatory Affairs (RA) & Clinical Affairs (Evident... Affairs and RA with focus on Clinical Affairs and Clinical Trial management for Medical … more
- Philips (Cambridge, MA)
- …of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with Software as Medical ... As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal ...Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally. + You're able to work in… 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… 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 ... requirements and desired marketing claims. + Author and/or review regulatory submissions, specifically device master files, ...count on, which includes: + A choice of national medical and dental plans, and a national vision plan,… 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
- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …councils, inspection support, and industry interactions. + Partner with critical stakeholders in Regulatory Affairs , Device Quality, and PharmSci to ensure ... medical devices, including stand-alone devices, combination devices, and Software as a Medical Device (SaMD). You will ensure that Quality System requirements… more
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …Massachusetts. This announcement is intended to fill multiple vacancies throughout the Veterans Affairs Medical Center in Bedford, MA. Available shifts could be ... is located in the Nursing Service (Mental Health) at the Bedford VA Healthcare Medical Center, in Bedford, Massachusetts. This is a full time position at 40-hours… 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
- J&J Family of Companies (Danvers, MA)
- … Medical Officer. The MSO will build clear and strong relationships between Medical Affairs , R&D, Quality, Regulatory , Clinical, Epidemiology to allow for ... in Danvers, MA. The MSO role is to provide medical safety stewardship for Medical Device...and safety communications. + Stakeholder Collaboration: Work closely with Medical Affairs , R&D, Quality, 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
- J&J Family of Companies (Danvers, MA)
- …dual-role position that combines field-based clinical research engagement, technical expertise in medical device support, and on call, bedside clinical support. ... and feedback ("Voice of Investigator") to Abiomed cross-functional partners such as R&D, medical affairs , marketing, sales, and education. JOB DUTIES + Provides… more