- Beckman Coulter Diagnostics (Brea, CA)
- …experience in:Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (eg CQM, CQE, CQA, RAC, ... and standards including compliance with Food & Drug Administration (FDA), Medical Device Single Audit Program (MDSAP), ISO13485, European Union Medical… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …in translational medicine (T0 - T1) or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical Development is ... Medical Director of CNS Early Assets, Global Medical Affairs , responsible for certain assets within...evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Ensure compliance with all regulatory requirements and internal policies for medical affairs activities. + Support regulatory submissions, including ... Kite, a Gilead company is hiring a **Senior Medical Manager** to support US Medical Affairs . As a Senior Medical Manager, you have both field-based as… more
- Abbott (Pleasanton, CA)
- …in a broader enterprise/cross-division business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society ... place to work for diversity, working mothers, female executives, and scientists This ** Regulatory Affairs Specialist I** will work on-site out of our Pleasanton,… more
- Sanofi Group (San Diego, CA)
- … Unit physicians, Outcome Liaisons, Medical Information). + Collaborate with US Medical Affairs , Regulatory , Legal, or other departments and external ... The Transplant MSL serves as an advanced field-based scientific professional for US Medical Affairs division of North American Pharmaceutical Operations. The SOT… more
- AbbVie (Irvine, CA)
- … documents/statements. + Supports regulatory interactions with R&D, Quality, Medical Safety and International Regulatory Affairs colleagues. + ... and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director of Regulatory Affairs - Soft Tissue Fillers supports regulatory … more
- BeOne Medicines (San Mateo, CA)
- …contact for one or more Global Product Teams (GPTs). + Collaborate with R&D, Commercial, Medical Affairs , and Regulatory Affairs to ensure access-related ... cross-functional alignment and communication. + Collaborate closely with Pricing, HEOR, Medical Affairs , Commercial, and Regulatory Affairs to drive… more
- Abbott (Alameda, CA)
- …Qualifications . 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... medical device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems standards,… more
- Abbott (Alameda, CA)
- …**Qualifications** + 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... medical device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices, drugs and/or biologics including Quality… more
- System One (San Diego, CA)
- …Development, Global Study Management and Monitoring (GSMM), Project Management, company Affiliates, Medical Affairs (MA), Regulatory , CMC, QA, Packaging ... + Actively participating in Trial Supplies Management Functional team, Study Team, Country Medical Affairs Affiliate & CSC Matrix Team Meetings providing all… more
