- Teleflex (Minneapolis, MN)
- …Cardiology environment. - Medical Device industry supporting Clinical and Medical Affairs , strongly preferred. - Proficient in Microsoft Word, Excel, and ... with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which… 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 ... 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
- 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 (Mounds View, 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
- 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
- Teleflex (Minneapolis, MN)
- …Cardiology environment. * Medical Device industry supporting Clinical and Medical Affairs , strongly preferred. * Proficient in Microsoft Word, Excel, and ... with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which… 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
- 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
- ManpowerGroup (Mendota Heights, 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 5 years of… more
- ManpowerGroup (Mendota Heights, MN)
- …performance. + Collaborate with internal teams such as marketing, quality assurance, regulatory affairs , supply chain, and finance to meet product specifications ... of experience in sourcing, procurement, or supply chain management, preferably in healthcare, medical device , or pharmaceutical industries. + At least 3 years of… more
