- Abbott (Burlington, MA)
- …of product complaints. Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies ... product evaluations in a timely manner. Executes product evaluations to develop a well-documented and...work experience **Preferred Qualifications** + 3+ years in MDR ( Medical Device Reporting) + Knowledge of the… 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 ... control system design, automation, and integration within regulated industries (preferably medical device or pharmaceuticals), demonstrating increasing levels of… more
- Olympus Corporation of the Americas (Westborough, MA)
- …ensure compliance. + Support the optimization of design control elements to comply with medical device regulations. + Implement product design with the ... security, cybersecurity, and equipment development oversight. Extensive knowledge of medical device design control requirements, system design and software… more
- Terumo Medical Corporation (San Francisco, CA)
- …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 (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 (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 ... such as quality plans and standard operating procedures. 9. Develop product /process assurance plans, which include all...CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485,… 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 ... System in accordance with applicable regulations for a global medical device corporation. + Help to establish...programs, rules and practices, including but not limited to product and patient safety, the health and safety of… more
- Microsoft Corporation (Redmond, WA)
- …in strategy, analytics, product planning, or related fields, with focus on device ecosystems and AI technologies. + 4+ years working with device market ... for AI experiences, growth, and monetization across the Windows device ecosystem. This role is central to shaping how...customer needs, and business goals. + Growth & Monetization: Develop and execute strategies to drive user growth, engagement,… 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 ... of relevant Medical Affairs experience in the Medical Device Industry. Advanced degree preferred (PhD,...FDA and international regulations, including, but not limited to medical product communications and response to unsolicited… more
- Edwards Lifesciences (Portland, OR)
- …(RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) or related medical device , clinical, or Certification in RDCS (Registered Diagnostic ... + Knowledge and understanding of cardiovascular science + Moderate understanding of medical device regulatory requirements and documents, device … more