- Teleflex (Wayne, PA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... expertise in management of prostate cancer. As a senior member of the Teleflex Medical Affairs team within Clinical and Medical Affairs (CMA) across… more
- State of Colorado (Denver, CO)
- …Job Type Full Time Job Number NAA-01946-08.2025 Department Department of Local Affairs Division Division of Housing Opening Date 08/26/2025 Closing Date 9/9/2025 ... open to residents of the State of Colorado. About the Colorado Department of Local Affairs The Department of Local Affairs (DOLA) serves as the primary interface… more
- J&J Family of Companies (Titusville, NJ)
- …publications emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug/ device regulatory strategies and ... interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality monitoring &… more
- Medtronic (North Haven, CT)
- …Marketing + Marketing Operations + Supply Chain and Logistics + Quality Assurance, Medical and Regulatory Affairs + Marketing Communications + Marketing ... 2 years. **Nice to Have** + Degree in Marketing, Business, R&D + MBA + Medical Device experience + Highly effective written and verbal communication skills. +… 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
- Cook Medical (Bloomington, IN)
- Overview The Packaging Engineer 2 uses their experienced in medical device packaging to design and develop solutions for new and modified products. This includes ... packaging activities with a cross-functional team including SBU Product Management, Regulatory Affairs , Operations, Quality Assurance, Clinical Affairs ,… more
- Bausch + Lomb (Harrisburg, PA)
- …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
- Actalent (Grand Rapids, MI)
- …related field. + 5+ years of experience in a regulated pharmaceutical/ medical device industry. + Hands-on experience in Regulatory Affairs with growing ... Job Title: Quality Assurance Associate Job Description The Regulatory Affairs Specialist/Compliance Specialist/QA Specialist plays a crucial role in overseeing … more
- Edwards Lifesciences (Austin, TX)
- …pathology and physiology or Business Unit area of expertise + Moderate understanding of medical device regulatory requirements and documents, device ... + Knowledge of cardiovascular physiology and structural heart anatomy + Previous medical device Clinical Research experience in cardiology + Clinical research… more
- Terumo Medical Corporation (Elkton, MD)
- …TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide ... Management Office (PMO), Product Development, Process Development, Quality, Marketing, Regulatory Affairs , Operations, Supply Chain, Logistics and Distribution… more
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