- 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
- 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
- Medtronic (Mansfield, 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
- 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
- Bausch + Lomb (Providence, RI)
- …+ 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
- 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 (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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …Takeda Oncology including Translational Medicine, Clinical Sciences, Global Regulatory Affairs , the Oncology Business Unit (Commercial and Medical Affairs ... and external diagnostic partners, and supporting health authority meetings and regulatory submissions (PMAs etc). This role will partner closely with key… more
- Medtronic (Boston, MA)
- …prioritization. * Collaborate with Verification & Validation, Systems Engineering, and Regulatory Affairs to ensure appropriate test coverage and documentation. ... + Knowledge in product development, project management, and commercialization in the medical device industry + Strong communication and teamwork skills; must… more
- Medtronic (Boston, MA)
- …best practices, test automation strategies, and emerging technologies relevant to medical device software. + Champion and implement Lean-Scaled Agile ... test coverage and efficiency. + Ensure all software verification activities adhere to relevant medical device regulations (eg, FDA 21 CFR Part 820, ISO 13485,… more
- Integra LifeSciences (Braintree, MA)
- …communicating testing activities. The role works with Product Development, Project Management, Regulatory , Marketing and Medical Affairs . **ESSENTIAL DUTIES ... in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs . Support Design Reviews, Technical Reviews, and Gate… more
- Edwards Lifesciences (Providence, RI)
- …surgery or interventional cardiology are strongly preferred; candidates with other relevant medical device clinical sales support experience will be considered + ... Director and will collaborate with multiple departments including Sales, Clinical Affairs , Marketing, Quality, Regulatory , and Education. After extensive… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Co-leads CMC teams with functional areas from quality, process experts, product experts, device experts, and regulatory affairs . + Works with supervisor ... & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product / process. + knowledge, capability & improvement,… more