- Pall (Miami, FL)
- …System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations as they apply ... of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints.… more
- Cepheid (Miami, FL)
- … Affairs department, in addition to responses to global regulatory submissions following US and CE IVD approvals.Evaluation, acquisition, and implementation ... Sr Director of Clinical Research or VP of Clinical Affairs will ensure that Cepheid Clinical Affairs ...on experience in dealing directly with FDA and other regulatory agenciesProven track record of managing successful clinical audits… more
- Beckman Coulter Diagnostics (Miami, FL)
- …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
- System One (Malvern, PA)
- Job Title: Director of Regulatory and Medical Affairs Location: Malvern, PA Type: Direct Hire Essential Duties/Responsibilities: + Manage Regulatory and ... in life sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. + Strong… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Regulatory Affairs - Medical Device Requisition ID: 69746 Date: May 13, 2025 Location: Exton, Pennsylvania, US Department: Regulatory ... planet through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs , Medical is responsible for influencing department … more
- Otsuka America Pharmaceutical Inc. (Helena, MT)
- …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
- Medtronic (Mounds View, MN)
- …of experience in regulatory affairs **Nice to Have** + 4+ years of medical device regulatory affairs experience + Local to CO and willing to work ... Day in the Life** We are seeking a Senior Regulatory Affairs Specialist to join our team...Quality Management Systems (QMS) + Technical Writing + International medical device regulatory submission/approval experience, to include… more
- Abbott (Plymouth, MN)
- …+ Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus. + ... get on with their lives. **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist** to join Abbott's Electrophysiology Division on-site in… more
- Stryker (Redmond, WA)
- …to be based **Hybrid** in **Redmond, Washington.** **What you will do** As part of the Medical Regulatory Affairs team, you will work with the team to ... We are currently seeking a **Senior Regulatory Affairs Specialist** to join our ** Medical ** **Division**...certification or Advanced Degree (Masters in Regulatory Affairs ). + Previous experience with Class II/III medical… more
- Teleflex (Chelmsford, MA)
- …a science or engineering field, or equivalent work experience. * 5+ years of Medical Device Regulatory Affairs experience, domestic and international. 3 ... Sr. Regulatory Affairs Specialist **Date:** May 8,...:11911 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
