- Oracle (St. Paul, MN)
- …driving Oracle's success and competitiveness in the healthcare and life sciences sector. As a Medical Device Regulatory Affairs Strategist, you will work ... with SaMD in areas such as Regulatory Affairs , Quality Compliance, Product Development, etc. in medical... Affairs , Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring… 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
- GRAIL (St. Paul, MN)
- …management within the IVD, medical device , or pharmaceutical industries. + Regulatory affairs and IVD device experience preferred. + An advanced ... 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. + Effective… 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
- 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
- Medtronic (Fridley, MN)
- …seeking a dynamic and experienced communications professional to join our Clinical Research, Medical Science, and Regulatory Affairs organization. As a ... biotech) + Experience with global regulatory requirements + Experience with medical device industry groups **Physical Job Requirements** The above statements… more
- Bausch + Lomb (St. Paul, MN)
- …+ Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device , cosmetics or ... and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative...**We offer competitive salary & excellent benefits including:** + Medical , Dental, Eye Health, Disability and Life Insurance begins… 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
- Abbott (Maple Grove, MN)
- … Affairs departmental responsibilities and processes + Familiarity of medical device regulatory requirements and submission/registration activities. + ... Regulatory Services managing projects related to harmonized regulatory processes in Abbott's Medical Device...Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) + 5+ years'… 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 (St. Paul, MN)
- …varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required. Medical device industry experience preferred. ... and preclinical studies for product concept feasibility and formal regulatory submission. + Plan, coordinate, and conduct empirical and...or, Design Validation and GLP study experience in the medical device industry. + Demonstrated ability to… 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
- 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
- Medtronic (Mounds View, MN)
- …with deep knowledge of ISO 14971 to lead risk management strategy for our medical device products (Capital and disposable). This role is pivotal in ensuring ... + Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs , to define and implement systems engineering processes… more
- Patterson Companies, Inc. (St. Paul, MN)
- …and service performance. + Collaborate with internal teams (marketing, quality assurance, regulatory affairs , supply chain and finance) to ensure product ... of experience in sourcing, procurement, or supply chain management, ideally in healthcare, medical device , or pharmaceutical industries. + At least 3 years of… more