- GRAIL (Menlo Park, CA)
- …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
- BeOne Medicines (Emeryville, CA)
- **General** **Description:** The Director, Regulatory Affairs , Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... implementing regulatory diagnostic and medical device strategies as applicable, for the designated program to support clinical trials where necessary, and… more
- Terumo Neuro (Aliso Viejo, CA)
- **13011BR** **Title:** Principal, Regulatory Affairs **Job Description:** Responsible for establishing, preparing, and leading the strategy for worldwide product ... solutions. + Coach, review, and delegate work to junior regulatory affairs professionals; may manage large projects...by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications,… more
- Twist BioScience (South San Francisco, CA)
- …at multiple levels within all functional departments, including Quality Assurance, Regulatory Affairs , Supplier Quality, Supply Chain, Quality Control, ... a GMP, Biotechnology, Pharmaceuticals or another Regulated Industry.Experience in Quality Assurance/ Regulatory requirements in medical devices, IVD, EU IVDR/MDR,… more
- Terumo Neuro (Aliso Viejo, CA)
- …following areas: + Research & Development (R&D) + Equipment/Tool Design + Marketing + Regulatory Affairs + Quality + Supply Chain Job duties: Support development ... of medical device products with work including writing or verifying specifications, designing new products, fixtures, test processes, equipment and specifying… more
- Terumo Neuro (Aliso Viejo, CA)
- …operation process/documentation. Ensure seamless coordination across functions, particularly with R&D, Regulatory Affairs , Compliance, and TIS marketing teams to ... operations, or commercial support. 3. Experience in healthcare, biotech, or medical device industry. 4. Strong project coordination and written and verbal… more
- Terumo Neuro (Aliso Viejo, CA)
- …functionally with Associates across all departments in R&D, Operations, Quality, and Regulatory Affairs to achieve company objectives and resolve project issues. ... related field. 2. Minimum eight (8) years of relevant work experience in medical device industry. 3. Minimum two (2) years of management experience. 4. Knowledge… more
- Terumo Neuro (Aliso Viejo, CA)
- …functionally with Associates across all departments in R&D, Operations, Quality, and Regulatory Affairs to achieve company objectives and resolve project issues. ... related field. 2. Minimum six (6) years of relevant work experience in medical device industry. 3. Minimum one (1) year of management experience. 4. Knowledge of… more
- Teleflex (San Francisco, CA)
- …an optimal customer experience. Collaborating with Marketing, Sales, Engineering and Clinical & Medical Affairs on key projects and initiatives, the CSS utilizes ... dictate the work schedule. **Specialized Skills / Other Requirements** + 2+ years of Medical Device Industry experience. + 3+ years of experience in a business… more
- 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
