- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Files, etc.) + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and non- Medical device products and software + ... to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Support the...preferred + Minimum of 10 years of directly related Regulatory Affairs experience in medical … more
- J&J Family of Companies (Santa Clara, CA)
- …functional teams including but not limited to R&D, Supply Chain/Manufacturing, Clinical and Medical Affairs , Regulatory Affairs , Service, Marketing, in ... regulated industry with at least 12 years in a medical device industry. + A minimum of...but not limited to R&D, Operations, Commercial, Supply Chain, Regulatory Affairs , Medtech/Enterprise, to assure quality and… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …issues. The Medical Director will have supervisory responsibilities over the internal medical laboratory and other medical affairs teams. These teams ... as requested or required + Develop and manage the Medical Affairs to ensure effective and compliant...support clinical products + Ownership of on-time quality assessments, medical device reporting and health risk assessments… more
- Edwards Lifesciences (Los Angeles, CA)
- …+ Knowledge and understanding of cardiovascular science + Moderate understanding of medical device regulatory requirements and documents, device ... (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) or related medical device , clinical, or Certification in RDCS (Registered Diagnostic… more
- Cordis (Irvine, CA)
- …key clinical and scientific insights to internal stakeholders-such as Clinical Development, Medical Affairs , and Commercial teams, helping shape strategy and ... and medical information between KOLs, other investigators and the company's Medical Affairs , Marketing and R&D groups. + Propose strategic solutions to… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Action decision, as applicable. + Collaborates with leadership in Business Unit Quality, Regulatory Affairs , R&D, Operations, Service, Medical Affairs , ... field + Minimum of 10 years of experience in Quality or Regulatory function within the medical device industry, including experience with Class II or III… more
- Actalent (Vista, CA)
- …annual reports, control documents, etc. to FDA authorities. + File Vigilance Reports or Medical Device Reports to Competent Authority or FDA. + Review ... change control documents, ensuring correct filing category. + Represent Regulatory Affairs on interdepartmental project teams. +...+ Quality Management System (QMS) + Quality assurance + Medical device auditing + CAPA (Corrective and… more
- Bausch + Lomb (Sacramento, CA)
- …Management, Clinical/ Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device Safety, and Clinical ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… more
- J&J Family of Companies (Irvine, CA)
- …all relevant Clinical R&D partners and cross-functional partners (eg Global Strategic Marketing, Medical Affairs , Regulatory Affairs , Health Economics ... study team; o Cooperates with cross-functional teams (Research & Development, Complaint Handling, Quality/ Regulatory , Medical Affairs , Medical Safety) to… more
- Stryker (San Jose, CA)
- …Market** to support our Medical 's Digital Health division and portfolio Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) to ... & Development (R&D), Quality (QA/QC), Information Technology, Healthcare IT, Regulatory Affairs (RA) or Technology industry. +...strong technical skills. + Experience with Software as a Medical Device (SaMD) and Software in a… more