- Oracle (Salt Lake City, UT)
- …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
- Cardinal Health (Salt Lake City, UT)
- …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 (Salt Lake City, UT)
- …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. (Salt Lake City, UT)
- **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 (Salt Lake City, UT)
- …**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. (Salt Lake City, UT)
- …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
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …broader quality goals and regulatory landscapes. + Deep understanding of global medical device /IVD regulations (eg, FDA 803/806, MEDDEV, QSR 820, ISO 13485) ... Fields) with 6 years of experience in a regulated medical device /IVD industry employment position such as...industry employment position such as post-market surveillance, quality assurance, regulatory affairs , clinical affairs or… more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …and develop **use-related risk analysis (URRA)** and mitigation strategies in partnership with Medical & Regulatory Affairs . + Collaborate with ** ... Validation &** **Human Factors strategies** for successful submission in concert with Regulatory Affairs . + Conduct **gap analyses** of existing DVal/HF… more