- Twist BioScience (South San Francisco, CA)
- …in a GMP, Biotechnology, Pharmaceuticals or another Regulated Industry.Experience in Quality Assurance/ Regulatory requirements in medical devices , IVD, EU ... at multiple levels within all functional departments, including Quality Assurance, Regulatory Affairs , Supplier Quality, Supply Chain, Quality Control,… more
- Meta (Burlingame, CA)
- …a scientific discipline or equivalent work experience 6. 3+ years of industry experience in medical device regulatory affairs or related industry 7. ... regulatory affairs specialist to join our medical devices compliance team. You will get...get to work on wearables and Software as a Medical Device (SaMD) applications for the US… more
- 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
- Abbott (Alameda, CA)
- …. 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) is a plus. ... regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . ....device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices … more
- BeOne Medicines (San Mateo, 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 ...externally with a solid background in medical devices /diagnostic development regulations and associated regulatory deliverables.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and devices . . **Global Regulatory ... regulatory initiatives focused on combination products and devices . Ensure regulatory conformance and consistency across...experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of… more
- Abbott (Alameda, CA)
- …+ Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices . + Experience of working within ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Alameda, CA)
- …+ Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Edwards Lifesciences (San Francisco, CA)
- …the ground up. **How you'll make an impact:** + As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior ... Manager, Medical Affairs ) is responsible for providing scientific...across TMTT. The Senior Manager will be an experienced medical device professional with strong scientific acumen… more
- Edwards Lifesciences (San Francisco, CA)
- Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate ... environment with cross-functional collaborators + Substantial knowledge and understanding of medical affairs policies, procedures, and guidelines, including … more
- Abbott (Alameda, CA)
- …monitor the performance of marketing programs, and adjust tactics as needed + Partner with Regulatory Affairs , Medical Affairs , Legal, and OEC colleagues ... years of experience in product marketing in healthcare, pharmaceutical, medical device , or a regulated industry. **Preferred...of applicable regulatory standards and requirements for medical devices or Rx products preferred. The… more
- ThermoFisher Scientific (South San Francisco, CA)
- …Clinical Practices is required. + 4+ years working in the In Vitro Diagnostic or Medical Device Industry; companion Diagnostic experience is a plus. + 4+ years ... **Location/Division Specific Information** This position is part of the Regulatory and Clinical Affairs organization which ensures...count on, which includes: + A choice of national medical and dental plans, and a national vision plan,… more
- Abbott (Alameda, CA)
- …and manage the digital health analytics + Work cross functionally with market access, regulatory affairs , medical and clinical resources to deliver on ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Alameda, CA)
- …and alignment with strategic objectives + Partner with cross functional teams including medical affairs , product, regulatory , market access, finance and ... the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000… more
- Abbott (Alameda, CA)
- …(MEG) and No Product Return (NPR) will lead global medical device vigilance, post-market surveillance, and regulatory reporting for Abbott's Diabetes Care ... Minimum 8-10 years of experience in Quality Systems, Regulatory Affairs , or Quality Assurance within the medical device industry. * At least 5 years of… more
- Edwards Lifesciences (San Francisco, CA)
- …+ Knowledge of cardiovascular physiology and structural heart anatomy + Previous medical device Clinical Research experience in cardiology + Clinical research ... Clinical Coordinator/CRA certification) + Prior clinical research experience with Class III Medical Devices including PMA, IDE and 510(k) + Excellent written… more
- Genentech (South San Francisco, CA)
- …early and late stage research and development of pharmaceutical products, digital health, and medical devices . As a member of the R&D Law Group, this **"Senior ... support Research and Early Development, Clinical Operations, Global Product Development, and Medical Affairs functions by providing strategic legal advice to… more
- Abbott (Alameda, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... combination of appropriate education and experience. + Experience working on medical device studies and/or in-vitro diagnostics studies preferred. Pharmaceutical… more
- Stryker (Fremont, CA)
- …do:** **Technical Responsibilities:** + Works with Divisional Leadership, KOLs, Marketing, Clinical Affairs and Regulatory Affairs and regional organizations ... internal stakeholders. + Works with Divisional Leadership, Marketing, Clinical Affairs and Regulatory Affairs and...desired):** **Preferred Skills** **/ Tools:** + Deep experience in medical device clinical research + 10+ years… more
- Edwards Lifesciences (San Francisco, CA)
- …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
