- US Tech Solutions (San Bruno, CA)
- …Quality System Regulations, ISO 13485, and integration of best practices from the medical device industry. **Documentation and Support:** 1. Support the creation ... and support CAPA, complaints, audits, and overall QMS functions. **Experience:** ** Medical Device Software Experience:** 1. Proven experience in software… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …management of device /drug master files, technical dossiers and/or medical device dossiers in support of combination product submissions in both domestic ... within the platform and author regulatory files (eg master files, GSPR packages, medical device dossiers) and respond to health authority responses as needed.… 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 ... Japanese Pharmaceutical Affairs Laws, the Canadian Quality System Regulation, and the Medical Device Directive. **Job Details/Responsibilities** + Manage a team… more
- Terumo Medical Corporation (Greenville, SC)
- …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 ... _Serving as_ a subject matter expert (SME), provides directed product support education, training and insight in the proper...Prior experience as a Field Clinical Specialist with a medical device company is preferred. It is… more
- Terumo Medical Corporation (Tampa, FL)
- …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 ... Summary** Serving as a "subject matter expert" (SME), provide product support, education, training and insight regarding the proper...Prior experience as a Field Clinical Specialist with a medical device company is preferred. + Prior… more
- J&J Family of Companies (Santa Clara, CA)
- …Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated ... or Polymer Science or other relevant engineering degree and 10 years' experience in the medical device industry or a Master's Degree and 8 years' experience in … more
- J&J Family of Companies (Danvers, MA)
- …**You will be responsible for** : + Have Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions ... core focus will be regulatory leadership of a new product platform under investigational use, providing both clinical and...Regulatory Affairs experience (5+ w/ Advanced Degree) in the Medical Device industry with a track record… more
- Stryker (Irvine, CA)
- …science, engineering or related discipline. + 4+ years' related experience required. + Medical device industry experience required. + Familiarity with New ... Sigma Green or Black belts are preferred. + Experience with the medical device development lifecycle, including risk management and design/process verification… more
- Cardinal Health (Mansfield, MA)
- …independently and as a member of a team. + Knowledge of Medical Device design controls and Stage Gate product development process, preferred. + Applies ... to detail and working knowledge of regulations for the medical device industry are essential. The engineer...using established Change Development Process. + Conduct and/or orchestrate device and component testing. + Conduct product … more
- Terumo Medical Corporation (Somerset, NJ)
- …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 ... 15-20 years of experience in a combination of commercial medical device or life science roles of...key stakeholders across the business, including Commercial Operations, New Product Development, Medical Affairs, Finance, Logistics and… more