- 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
- 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
- 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
- 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
- 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
- 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
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- …Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device ), with 3-5 years in in pharmaceutical quality, with specific ... or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs . **Competencies** **Accountability for Results -** Stay focused… more
- Edwards Lifesciences (St. Paul, MN)
- …patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… 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
- Edwards Lifesciences (St. Paul, MN)
- …assigned studies + Contributing to additional initiatives that shape the future of medical device development **What you'll need (Required):** + Ph.D. or ... patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you… more