- 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
- Oracle (Providence, RI)
- …success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work in collaboration ... across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs. **Responsibilities** **Preferred… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing ... variations) around small molecule drug substance, drug products and drug- device combination products. Ensure compliance with global ...local and/or global functional units [OPC CMC Global Regulatory Affairs , Global… more
- Olympus Corporation of the Americas (Westborough, MA)
- …technologies aligned with the Business Unit priority. + Interface with International Regulatory Affairs Team to ensure global planning considerations ... + Minimum of 10 years of Regulatory Affairs experience, ideally within the medical device ... Device . + Demonstrated leadership in managing the global submission process for regulatory approvals across… 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 years ... more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports … 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. + Minimum ... of a high-growth, innovative team, this position oversees collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will… more
- GRAIL (Providence, RI)
- …with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For...IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device … more
- J&J Family of Companies (Raynham, MA)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... We are searching for the best talent for a ** Regulatory Affairs Specialist II** to support our...Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are **required** .… more
- Evident Scientific (Needham, MA)
- …operations, supporting submissions, inspections, and QMS compliance activities. Reporting to the Global Director of Regulatory Affairs - Clinical Business, ... across global and regional projects. **Key Responsibilities** ** Regulatory Affairs (US Focus)** + Act as... Affairs (US Focus)** + Act as US regulatory lead for clinical and medical device … more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory ... Under the mentorship of the Sr. RA Manager of Regulatory Affairs , they are responsible for the..., they are responsible for the development of complex global regulatory strategies and preparation of … more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …BS in other field acceptable with appropriate level of experience. + Minimum 1-2 years Regulatory Affairs experience in medical device or in vitro diagnostic ... absorbable devices. Under the mentorship of the Manager of Regulatory Affairs , the position will provide technical...audits and inspections. + Support development and execution of global regulatory strategies by collaborating closely with… 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
- 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
- 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
- IQVIA (Boston, MA)
- **Manager, Medical Affairs Strategy** **Overview** IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services ... of innovative medical treatments. Our diverse client base includes the global top 20 pharmaceutical, medical device , and biotechnology companies… more
- Avania (Boston, MA)
- …- Regulatory & Market Access Interns x2 We are seeking two, part-time Medical Device Regulatory Affairs & Quality Interns to join the Advisory team for ... outreach efforts. + Content Development + Contribute to creation of medical device regulatory and quality-focused white papers, blogs, and marketing materials.… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Takeda Pharmaceuticals (Boston, MA)
- …with key functions across Takeda Oncology including Translational Medicine, Clinical Sciences, Global Regulatory Affairs , the Oncology Business Unit ... and clinical data integration. + Understanding of key considerations relevant to global regulatory requirements + Experience developing team culture, resolving… more
- Olympus Corporation of the Americas (Westborough, MA)
- …deliverables from assigned projects as required by the SDLC and will support Regulatory Affairs ' efforts in creating submission materials for various ... Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs , etc. + Independent organizational and time management skills… more