- Terumo Medical Corporation (Elkton, MD)
- …particularly ISO 13485 and FDA regulations. + Familiarity with audit processes and regulatory requirements within the medical device industry. + Proficiency ... manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- Terumo Medical Corporation (Elkton, MD)
- …particularly ISO 13485 and FDA regulations. + Familiarity with audit processes and regulatory requirements within the medical device industry. Skills: + ... manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range...of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in… more
- Gilead Sciences, Inc. (Washington, DC)
- …Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and devices . . **Global Regulatory ... global CMC regulatory initiatives focused on combination products and devices . Ensure regulatory conformance and consistency across markets, maintaining… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …This position is specifically focused on regulatory affairs for Software as a Medical Device (SaMD) products. The candidate will need deep expertise in FDA ... Strong knowledge of risk management processes (ISO 14971) and cybersecurity for medical device . **Preferred Qualifications:** + Regulatory Affairs… more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …clinical environments + Previous experience with heavy consumable/disposable medical devices . + Strong grasp of global regulatory requirements and design ... or related field (PhD or Master's preferred) + 15+ years of progressive experience in medical device R&D, with at least 5 years in a leadership role +… more
- Abbott (Pleasanton, CA)
- …the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices , nutritionals and branded generic medicines. Our 114,000 ... levels in the organization. + Minimum of ten (10) years' experience in medical device development and/or other highly regulated industry + Previous experience… more
- Trinity Health (Muskegon, MI)
- …time **Shift:** **Description:** Coordinator needed to help regionalize the Cardiac Device Management program. Ensures quality and regulatory compliance related ... of evidence-based practice education and competencies. * Ensures quality and regulatory compliance related to cardiac device standards using project… more
- Bausch Health (Bothell, WA)
- …progress and impact. We are seeking an Executive Director, Clinical Development for our Medical Device Aesthetics business (Solta) to be a key contributor to the ... research teams, extensive operational experience in all aspects of medical device clinical studies, and a strong...least 10 years of experience in clinical research for medical devices + At least 5 years… more
- Philips (Plymouth, MN)
- …therapy devices , cardiovascular products, structural heart disease, and medical imaging technologies and/or experience with regulatory pathways, clinical ... **R&D Program Manager - Medical Device NPD (Plymouth, MN)** We...industry, with proven experience managing projects involving disposable medical devices . + Experience with imaging-guided… more
- State of Colorado (Denver, CO)
- …durable medical equipment tracking, repair scheduling, service documentation, and regulatory compliance. This role will collaborate with the Central Medical ... Safety Checks/Weight Scale Calibrations: + Supports the safety, functionality, and regulatory compliance of electrically powered medical equipment and integrated… more