- Oracle (Sacramento, CA)
- …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
- Abbott (Alameda, CA)
- …process. + 3+yearof Regulatory Affairs or Quality experience within Medical Devices is preferred. Experience with review of labeling, promotional, and or ... SharePoint. + Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs ,… more
- Oracle (Sacramento, CA)
- …and industry collaboration around AI in healthcare. Required Qualifications + 8+ years in medical device regulatory affairs or regulatory ... deep regulatory and scientific leadership for AI-enabled medical device solutions. This role sits within...as a reviewer, regulatory scientist, or senior regulatory affairs leader. + Demonstrated experience reviewing… more
- GRAIL (Menlo Park, CA)
- …, 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
- Grifols Shared Services North America, Inc (San Diego, CA)
- …countries and regions. Grifols Diagnostic Solutions in San Diego, CA is seeking a Regulatory Affairs Specialist III. The Regulatory Affairs Specialist ... for success in this position. To qualify for the Regulatory Affairs Specialist III role, candidates must...reagent chemistry, laboratory automation, and software components of IVD medical devices . + Strong oral and written… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …(read, write and speak). + Minimum of 5 years of experience in Regulatory Affairs within the medical device industry, specifically for Class II and/or ... of possible** with us. **Job Summary** The Senior Specialist, Regulatory Affairs plays a key role in...a key role in ensuring Becton, Dickinson and Company's medical devices and Advanced Patient Monitoring Business… more
- Terumo Neuro (Aliso Viejo, CA)
- …assigned clinical reports, documents and scientific presentations in cooperation with the Clinical, Medical , & Regulatory Affairs Teams, KOLs and physician ... a difference in people's lives every day? We're a medical devices company that develops innovative neuroendovascular...a medical writer for pharmaceutical, CRO, or medical device clients). 4. Excellent writing and… more
- J&J Family of Companies (Irvine, CA)
- …all relevant Clinical R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs , Regulatory Affairs , Health Economics ... and Device Development and Regulation, Operational Excellence, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research,… more
- Stryker (San Jose, CA)
- …Science, or a related field. + 8+ years of professional experience, including work in medical device regulatory affairs or a closely related field. ... in International Regulatory Affairs , you will shape global regulatory strategies that accelerate access to medical technologies while protecting patients… more
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, Regulatory Affairs , Device works with internal and external ... factors testing, device risk analysis (ISO 14971) and other global regulatory requirements for Allergan's devices and combination products. This role is… more
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