- Philips (Plymouth, MN)
- …include a strong understanding of new product development processes, stage-gate methodologies, and regulatory and quality standards (eg, FDA , ISO 13485, EU MDR). ... cross-functional core teams (eg, PMO, R&D, Software, Marketing, Quality, Regulatory , Industrialization, and Clinical) while managing internal and external partners… more
- Sumitomo Pharma (St. Paul, MN)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Olympus Corporation of the Americas (Brooklyn Park, MN)
- …+ Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment. + Strong working knowledge of technical ... Management practices, Corrective and Preventative Actions, andregulatory requirements such as FDA QSR's, ISO13485, ISO 14971, ISO 11135, EUMDR and HumanFactors. +… more
- Medtronic (Fridley, MN)
- …activities. + Support regulatory submissions by contributing human factors documentation for FDA and EU MDR compliance. **Location** : Fridley, MN + _This is an ... life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with...partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical… more
- Fujifilm (St. Paul, MN)
- …States. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... changes, post-market surveillance, and product obsolescence. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a… more
- Fujifilm (St. Paul, MN)
- …Other + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... Account Manager will be responsible for sales of the Fujifilm Healthcare Americas Corporation's (HCUS) full portfolio (Endoscopy, Modality Solutions, and Medical… more
- Medtronic (Minneapolis, MN)
- …can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down ... adhere to company policies and procedures + Adheres to financial, regulatory , quality compliance standards and requirements. **Influence and Selling:** + Identify,… more
- Fujifilm (St. Paul, MN)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... well as clinical performance and utility of assays. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier… more
- Medtronic (Plymouth, MN)
- …can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down ... of life-changing medical technology to patients worldwide. Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can… more
- Teleflex (Plymouth, MN)
- …of people's lives. Through our vision to become the most trusted partner in healthcare , we offer a diverse portfolio with solutions in the therapy areas of ... people, purpose-driven innovation, and world-class products can shape the future direction of healthcare . Teleflex is the home of Arrow (TM) , Barrigel (TM) ,… more