- Oracle (Bismarck, ND)
- …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 (Bismarck, ND)
- …and industry collaboration around AI in healthcare. Required Qualifications + 8+ years in medical device regulatory affairs or regulatory ... deep regulatory and scientific leadership for AI-enabled medical device solutions. This role sits within...as a reviewer, regulatory scientist, or senior regulatory affairs leader. + Demonstrated experience reviewing… more
- GRAIL (Bismarck, ND)
- …, 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. (Bismarck, ND)
- **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
- Fujifilm (Bismarck, ND)
- …**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. (Bismarck, ND)
- …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
- Cardinal Health (Bismarck, ND)
- …data analysis & regulatory requirements. + Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific ... develop high-quality clinical documents. Extensive knowledge of the European medical device guidelines/regulations such as MEDDEV and...and Medical Affairs , Clinical or Regulatory … more
- Oracle (Bismarck, ND)
- …our quality systems and regulatory readiness for AI-enabled Software as a Medical Device (SaMD) and digital health solutions. This role sits within HDI's ... ** Regulatory & Medical Device organization.**...ISO 13485, and SOC2 alignment. + Experience partnering with regulatory affairs and product teams on submissions.… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …chains. The manager will collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs , and Supply Chain to ensure the integrity and ... + Collaborate with Commercial and Clinical Supply Chain and Regulatory Affairs to ensure timely and compliant...years of experience in a regulated industry (pharmaceutical or medical device ), with 3-5 years in Quality… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …Minimum 5 - 7 years of experience in a regulated industry (pharmaceutical or medical device ), with 3-5 years in pharmaceutical quality, with specific experience ... TrackWise, or similar. + Certification in DEA compliance, Quality Assurance, or Regulatory Affairs . **Disclaimer** This job description is intended to describe… more