- Cedars-Sinai (Beverly Hills, CA)
- …Los Angeles and beyond. **Req ID** : 11799 **Working Title** : Lead Regulatory Coordinator - Medical Network **Department** : CA Heart Foundation **Business ... you ready to be a part of breakthrough research?** The Lead Regulatory Coordinator prepares and submits large and/or complex protocols and supporting documentation… more
- Caldera Medical (Westlake Village, CA)
- …Life for Women! Message from the Hiring Manager: In your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory ... submit and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Abbott (Santa Clara, CA)
- …broader enterprise/cross-division business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Medtronic (Irvine, CA)
- …review of advertising and promotional material to ensure that it meets all medical , legal, and regulatory (MLR) process requirements. + Facilitate review ... for Neurovascular Ad Promo process, providing guidance to authors and reviewers on regulatory and internal policy requirements. + Support the preparation of US and… more
- GRAIL (Menlo Park, CA)
- …, development, clinical affairs, quality, or program management within the IVD, medical device, or pharmaceutical industries. + Regulatory affairs and IVD ... strong business partnering skills. + Demonstrated knowledge of US and international regulatory frameworks and processes for medical device development and… more
- Terumo Neuro (Aliso Viejo, CA)
- …clinical reports, documents and scientific presentations in cooperation with the Clinical, Medical , & Regulatory Affairs Teams, KOLs and physician investigators. ... scientific experience. 3. Demonstrated experience in the development of regulatory / clinical submissions (preferably as a medical ...of regulatory / clinical submissions (preferably as a medical writer for pharmaceutical, CRO, or medical … more
- Lilly (San Diego, CA)
- …research organizations to enable the discovery and early development portfolio and strategy ** Regulatory & Medical Affairs Support** + Partner with regulatory ... on IND strategy, FDA interactions, and global development planning + Contribute medical expertise to regulatory submissions and agency communications + Support… more
- Abbott (Pleasanton, CA)
- …cross-functional project teams** to drive supplier quality initiatives, ensuring alignment with medical device regulatory standards (eg, FDA, ISO 13485). + ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …medicine (T0 - T1) or early development (phase 1) assets either within Medical Affairs, Regulatory Affairs, or Clinical Development is preferred. + Minimum ... CNS disorders, we are seeking a skilled and experienced Medical Director of CNS Early Assets, Global Medical...and strong competency with the US healthcare system and regulatory landscape is required for this role. + Stay… more