- Oracle (Providence, RI)
- …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 (Providence, RI)
- …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
- GRAIL (Providence, RI)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... 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. + Effective… 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 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
- 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 ... beyond traditional medical devices. This leadership role leads an OSTA Core Regulatory Affairs Team and provides world-class regulatory strategies for… 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 ... Specialist II contributes to the digital transformation in the medical device space. The role focuses on executing regulatory activities, monitoring evolving… 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
- 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...in a highly regulated industry **required** , preferably in medical device (1+ years with Advanced Degree).… 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
- 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...functional representatives from other areas such as R&D, Manufacturing, Medical Affairs , and Quality to review and… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …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...collaboration and teamwork skills. + Working knowledge of US medical device regulations, 21 CFR 820 Quality… more
- Sanofi Group (Framingham, MA)
- …framework, providing expert guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle. ... we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as… 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 global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Trained Board Certification. + Minimum of 10-12 years of biotechnology/pharmaceutical/ medical device industry experience in medical affairs , medical ... Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified,… more
- Fujifilm (Providence, RI)
- …**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
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …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
- 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...+ Minimum of 6 years of experience in a medical device setting. + Experience in the… more
- Olympus Corporation of the Americas (Westborough, MA)
- …life sciences or related field. + Minimum of 8 years medical device industry experience post-degree preferably in Clinical Affairs /Operations, Medical ... and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures...or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs… more
- J&J Family of Companies (Raynham, MA)
- …of diverse technical backgrounds and efficiently executes the biological safety evaluation of medical device (MD) products as per internal procedures and global ... **Scientist Biocompatibility** to be in **Raynham, MA.** **Purpose:** Evaluates DePuy Synthes medical device products and materials for biological safety per… more
- Olympus Corporation of the Americas (Westborough, MA)
- …industry experience post-degree preferably in Clinical Research, Clinical Development or Medical Affairs within the medical device industry. + Minimum of ... + Strong cross-functional collaboration experience, including working with Legal, Compliance, Regulatory , Medical Affairs , and Clinical Operations. +… more