- Philips (Plymouth, MN)
- …of 8+ years' Regulatory Affairs experience within FDA regulated Medical Device /HealthTech product environments. Experience with Software as Medical ... reviewed with the RA management. + Driving improvement in regulatory aspects of the Quality Management System...Technical Documentation, 510(k), De Novo, PMA, and registrations of medical devices globally. + You're able to work in… more
- Abbott (Plymouth, MN)
- …years' experience in a regulated industry (eg, medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… more
- Philips (Plymouth, MN)
- …the right fit if:** + You've acquired 10+ years of experience working in Regulatory Affairs within the medical device industry; Experience with ... **Director, Regulatory Affairs- Software and Artificial Intelligence (Ultrasound)** The...Affairs and all key stakeholders including R&D, Product Management, Quality , Medical & Clinical Affairs, and other… more
- United Therapeutics (St. Paul, MN)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)**... experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area… more
- Grifols Shared Services North America, Inc (Minneapolis, MN)
- … submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Minnesota State (St. Cloud, MN)
- …& Services (RAS) course instruction The RAS is a professional Graduate program with a medical device focus that offers a Master of Science Degree and a Graduate ... Minimum of ten years of applicable industry experience in Regulatory Affairs, Clinical Research, Quality or Reimbursement...Time, six weeks of Paid Parental Leave, low cost medical and dental insurance with low deductibles ($250 -… more
- Abbott (Maple Grove, MN)
- …for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more ... help people with chronic pain or movement disorders, our medical device technologies are designed to help...CER related projects and processes. + Supports additional clinical, regulatory , quality and engineering related deliverable as… more
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- …degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of current global Good ... an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will...Previous experience of working in the global pharmaceutical and medical device industry. + Experience working with… more
- Medtronic (Minneapolis, MN)
- …for New Product Development (NPD) Systems Engineering, quality assurance, and regulatory compliance within the medical device industry. Ensure the ... and maintenance of high- quality , reliable, and safe medical devices that meet or exceed regulatory ...Control Charts, & ANOVA; CAPA; and Combination [pharmaceutical and medical device ] Products, (FDA 21 CFR Part… more
- Owens & Minor (St. Paul, MN)
- …of statistics, Minitab and/or other statistical software experience * Experience in a medical device manufacturing environment preferred * Medical Device ... our teammates. Owens & Minor teammate benefits include: + Medical , dental, and vision insurance, available on first working...in a manufacturing environment preferred * American Society for Quality (CQA, CQBA, CQE, CQM/OE) and/or Regulatory … more