- Abbott (Alameda, CA)
- …and preventative action of medical devices, including software as a medical device (SaMD), in-vitro, diagnostic devices, consumer devices, and accessories. ... Marketing to support mobile app deployment activities (for Software as a Medical Device projects). + Drives alignment during cross functional review and approval… more
- Medtronic (Irvine, CA)
- …Perform other duties as assigned or required. **To Be Successful in This Role** + ** Medical Device Experience:** Minimum of 4 years of relevant experience in ... medical device regulatory affairs. + **510(k) Submission Experience:** Proven history of successful 510(k) submissions or at least supporting US 510(k) filings. +… more
- Merck (Rahway, NJ)
- …support of Autoinjectors. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, manufacturing, and ... disciplines, with a minimum of 20 years of hands-on experience in medical device engineering, with a focus on Autoinjectors or combination products. + MS/MA… more
- Fresenius Medical Center (Lawrence, MA)
- …remotely. **PURPOSE AND SCOPE** Act as a Quality Business Partner for Software as a Medical Device and Non- medical software device engineering teams to ... ensure compliant products, engineering teams are supported with a value-added mindset, and Post Market Surveillance activities are performed, and actions derived **PRINCIPAL DUTIES AND RESPONSIBILITIES** . Works as part of software development team on new… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …to eight years plus related experience required and + Experience in a Medical device Manufacturing Environmentpreferred Knowledge, Skills and Abilities + Ability ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more
- Cook Medical (Bloomington, IN)
- …clinical, and regulatory affairs.- Provide leadership in the understanding of medical device regulations and best practices.- Manage conflict resolution ... Engineer degree and 5-8 years of experience- Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)- Professional… more
- Cook Medical (Bloomington, IN)
- …Engineer at Cook Polymer Technology performs and documents validations of medical device manufacturing processes. Responsibilities Responsible for providing ... as to provide a comparable background.* Minimum 3 years experience in medical device process development or process validation, understanding of processing… more
- Pentax Medical (Charlotte, NC)
- Position Opening: Director, Global Market Insights Why JOIN Us? We are an established medical device leader that is preparing for high growth. This means that we ... at strategic research consulting agencies or commercial role in the medical device field + Deep understanding of qualitative and quantitative data and… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …of complex electronic and software systems required. + Experience with medical device development including regulatory requirements required. Knowledge, Skills ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more
- Cook Medical (Ellettsville, IN)
- …clinical, and regulatory affairs.* Provide leadership in the understanding of medical device regulations and best practices* Manage conflict resolution ... Qualifications * Bachelors degree in a scientific discipline* Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO… more