- 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
- 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 ... To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing… more
- 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
- ManpowerGroup (Maplewood, MN)
- …of experience in regulatory affairs within the pharmaceutical or medical device industry, including experience with combination medical devices. + ... Our client, a leading organization in the medical device and pharmaceutical industry, is seeking a Regulatory Affairs Lead to join their team. As a … 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
- 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 (St. Paul, MN)
- …join our Global Regulatory Operations team and lead portfolio management of regulatory programs across medical device business units, international ... regulatory teams, and global regulatory operations. This role provides strategic leadership and stewardship...practices in program management, the Director will help achieve-and exceed- medical device division goals. This position serves… 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
- J&J Family of Companies (Plymouth, MN)
- …introduction of medical devices, preferable + Knowledge of regulatory affairs processes, applicable regulations and product filings/submissions, preferable ... quality system are conducted effectively. + Maintains up-to-date knowledge of global medical device regulations and standards affecting product development. +… 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