- Abbott (Sylmar, CA)
- …US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body. Knowledge of software ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- AbbVie (Irvine, CA)
- …from concept review to final approval, via close collaboration with legal, compliance, regulatory and medical . + Represent the US commercial strategy as a ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...deliver strong business performance for AbbVie's only eye care medical device. This person's key responsibilities are to lead… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … submission content (510(k), Technical Files, etc.) + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and non- Medical ... certification preferred + Minimum of 10 years of directly related Regulatory Affairs experience in medical devices and/or in vitro diagnostic field + Minimum of… more
- Sodexo (Los Angeles, CA)
- …+ A valid registered dietitian credential; + Prior experience with Medical Nutrition Therapy guidelines, regulatory standards, and evidence-based medicine ... experience **What You'll Do** + Be responsible for actively providing Medical Nutrition Therapy screening, assessing, and documenting the inpatient populations'… more
- Highmark Health (Sacramento, CA)
- …action to prevent further improper payments.Forwards case to the Credentialing and/or Medical Review Committee, law enforcement and regulatory agencies. + ... as needed to internal and external law enforcement and regulatory agencies, Credentialing or Medical Review Committee. + Engages in delivery of audit results… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …decision, as applicable. + Collaborates with leadership in Business Unit Quality, Regulatory Affairs, R&D, Operations, Service, Medical Affairs, Legal, Regional ... + Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with Class II or III devices,… more
- Actalent (Irvine, CA)
- …field (Master's preferred). + 8-10 years of experience in Quality Systems or Regulatory Affairs within the medical device industry. + Strong understanding of ... III Quality Systems Engineer to join our Quality and Regulatory team. This role is critical in ensuring the...integrity and compliance of marketing claims associated with our medical devices. The ideal candidate will have a strong… more
- Astellas Pharma (South San Francisco, CA)
- …from concept to delivery. + Experience working cross-functionally with compliance, regulatory , sales, and medical affairs teams. + Excellent communication ... countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping… more
- Gilead Sciences, Inc. (La Verne, CA)
- …reports (MDRs) and provide documented justifications for reportable and non‑reportable regulatory decisions. + Support medical device and combination product ... comprehensive support of these combination products. **Roles/Responsibilities:** + Monitor medical device standards for quality management system (QMS) updates to… more
- Danaher Corporation (Sunnyvale, CA)
- …In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) ... plus if you also possess previous experience in: + ISO 9001:2015 + Regulatory Intelligence Cepheid, a Danaher operating company, offers a broad array of… more