- Oracle (Madison, WI)
- …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 (Madison, WI)
- …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 (Madison, WI)
- …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
- GE HealthCare (Waukesha, WI)
- …+ A minimum of 4 years' experience in the medical device or pharmaceutical industry + Experience of regulatory people management/project management/program ... bodies globally. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is...regulatory bodies globally. + Manages a team of Regulatory Affairs professionals as well as an… more
- Otsuka America Pharmaceutical Inc. (Madison, WI)
- **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
- ThermoFisher Scientific (Milwaukee, WI)
- …or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager, Regulatory Affairs , you will play a crucial role in interpreting and ... requirements and desired marketing claims. + Author and/or review regulatory submissions, specifically device master files, ...count on, which includes: + A choice of national medical and dental plans, and a national vision plan,… more
- Lilly (Pleasant Prairie, WI)
- …include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairs **Additional Preferences:** + Broad knowledge of ... This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (… more
- Otsuka America Pharmaceutical Inc. (Madison, WI)
- …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