- 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
- J&J Family of Companies (Irvine, CA)
- …to drive alignment in strategy across different functions including Medical Affairs , Clinical Research, Quality, R&D, and Regulatory Affairs . + ... health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** ...subject area. + Minimum of 3 years of experience medical device , diagnostics, or pharmaceutical industry with… more
- AbbVie (Irvine, CA)
- …and brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs , ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...close liaison with the key governance bodies of Aesthetics Device Governance Board, Tri-Function Review and other ad hoc… more
- Olympus Corporation of the Americas (Westborough, MA)
- …subject matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards to the Olympus SDLC, ... projects as required by the SDLC and will support Regulatory Affairs ' efforts in creating submission materials...on regulations around health software development, and software for medical devices . + Collaborate on the update… more
- Actalent (Santa Clara, CA)
- …+ 2-3 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device or pharmaceutical industry. + Strong ... such as R&D, Manufacturing, and Regulatory . + Determine regulatory reportability and submit Medical Device Reports (MDRs) to the appropriate agencies. +… more
- Olympus Corporation of the Americas (Center Valley, PA)
- … & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health Care ... Medical Safety, risk management Vigilance or other Medical Device Experience ( Medical ...local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs… more
- J&J Family of Companies (Raritan, NJ)
- …external writers/vendors **required** . + Experience within the medical device industry and with clinical evaluation report regulatory requirements ... , Medical Safety, Post Market Surveillance, Clinical Affairs , Design Quality Engineers, R&D, and Regulatory ...**required** ; thorough understanding of global medical device regulations and guidelines (eg, FDA, EU MDR) **required**… more
- Caldera Medical (Westlake Village, CA)
- …or Class III medical devices is preferred. Experience in medical device component and material processing, design, and manufacturing. A comprehensive ... to ensure the ongoing reliability, compliance, and cost-effectiveness of our existing medical device products. This role is crucial for supporting products… more
- Astellas Pharma (Northbrook, IL)
- …include understanding of patent, trademark or copyright licensing, joint research and development, regulatory processes for medical devices , over the counter ... R&D legal transactions of the Research, Technology and Manufacturing (T&M), Development, Medical Affairs , and Rx+ functions. The position holder also provides… more
- Terumo Medical Corporation (Elkton, MD)
- …(TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for ... of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in...+ Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21… more