- GRAIL (St. Paul, MN)
- …, development, clinical affairs , quality, or program management within the IVD, medical device , or pharmaceutical industries is required. + Regulatory ... FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such...and international regulatory frameworks and processes for medical device development and approvals is required.… more
- Medtronic (Mounds View, MN)
- …profile._ + Bachelor's degree required with a + Minimum of 4 years of experience in medical device regulatory affairs experience + Or Advanced degree ... approval with the agencies. The Sr Regulatory Affairs Specialist is responsible for assessment of device...heart valve products + Experience with Software as a Medical Device + RAC Medical … more
- Cardinal Health (St. Paul, MN)
- …in related field or equivalent work experience, preferred + 2+ years' experience in Medical Device Regulatory Affairs /Quality experience preferred + ... **_What Regulatory Affairs contributes to Cardinal Health_**... and product development consulting services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory … more
- Philips (Plymouth, MN)
- **Intern - Regulatory Affairs - Minneapolis, MN - Summer 2026** We welcome individuals who are currently pursuing an undergraduate degree in engineering to join ... Philips as a Regulatory Affairs Intern in our Minneapolis location...**Your role** Join Philips Image Guided Therapy (IGT), a medical device manufacturer offering healthcare solutions in… more
- Abbott (Plymouth, MN)
- …of international regulatory affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly ... affairs function. **Preferred** **Qualifications** + 4+ years of related regulatory submission experience from medical device , pharmaceutical, or… more
- Medtronic (Minneapolis, MN)
- …in the medical device industry, particularly with Class III medical devices (PMA). + ** Regulatory Submission Expertise:** Proven experience preparing and ... connected, compassionate world. **A Day in the Life** **SENIOR REGULATORY AFFAIRS SPECIALIST** In collaboration with leading...**To Be Successful in This Role** + ** Medical Device Experience:** Direct experience… more
- Abbott (Plymouth, MN)
- …etc.), math, engineering, or medical fields. + Master's degree in Regulatory Affairs . + Regulatory experience with capital equipment including ... on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Regulatory Affairs Specialist II** to join our team on-site in Plymouth,… more
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory Strategy, Manufacturing facilities,… more
- ManpowerGroup (Maplewood, MN)
- …with Microsoft Office tools. + Some regulatory experience with drug and/or medical device products is preferred. + Ability to navigate a matrix environment ... organization in the healthcare industry_ , is seeking a ** Regulatory Affairs Coordinator** to join their team,...Declarations of Conformity. + Assist with state licensing for medical devices and drug products by reviewing requirements and… more
- Bio-Techne (Minneapolis, MN)
- …disease worldwide.** Pay Range: $62,300.00 - $102,350.00 **POSITION SUMMARY** Responsible for regulatory affairs activities to assist in regulatory ... submission, annual reports, registrations, and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards.… more
- Stryker (Bloomington, MN)
- …out Stryker's mission to make healthcare better. **Opportunities Available** As a Regulatory Affairs Intern, you will gain exposure to regulatory and ... legal frameworks, requirements, and processes that guide medical device development and compliance. In this role, you will support activities such as gathering… more
- Edwards Lifesciences (Minneapolis, MN)
- …the ground up. **How you'll make an impact:** + As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior ... Manager, Medical Affairs ) is responsible for providing scientific...across TMTT. The Senior Manager will be an experienced medical device professional with strong scientific acumen… more
- Fujifilm (St. Paul, MN)
- …**Job Description** **Responsibilities** + Manage and support the day-to-day legal affairs of assigned Medical Device businesses or ... Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with respect to healthcare… more
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory… 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 ... disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives… more
- Abbott (Maple Grove, MN)
- …MDR submissions + 3-5+ years of experience in clinical research, quality systems, or regulatory experience in medical device + Understanding of regulations, ... our Structural Heart Products combines understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to… more
- Philips (Plymouth, MN)
- …a master's degree or higher in areas such as Medical /Clinical Affairs / Medical Safety in the Medical Device industry strongly preferred. Prior bedside ... + Your skills include a strong of relevant standards and regulations for the medical device industry (ISO, IEC, etc.). You have strong knowledge and… more
- Philips (Plymouth, MN)
- … Medical /Clinical Affairs or Medical Safety/ Medical Affairs Risk Management in Meical Device industry. Prior hands-on bedside/clinical experience ... ** Medical Safety Manager, Complaints Handling** The Medical...assessments on complaints related to harm to assist in regulatory reportability determination and serves as the primary clinical… more
- Edwards Lifesciences (Minneapolis, MN)
- …+ Knowledge of cardiovascular physiology and structural heart anatomy + Previous medical device Clinical Research experience in cardiology + Clinical research ... patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you… more
- Philips (Plymouth, MN)
- ** Medical Education Program Specialist** You will be responsible for the development, facilitation, execution, documentation, and monitoring of our customer-facing ... Structural Heart Disease (SHD) medical training and educational programs as part of a...forecasting, while maintaining vendor relationships and financial compliance. Uphold regulatory standards and audit readiness for all educational activities,… more
