- Kelly Services (Seattle, WA)
- …and ongoing operation of molecular diagnostic products are fully compliant with global regulatory frameworks, including FDA, CLIA, CAP, IVDR, and other ... & Oversee Regulatory Submissions:** Guide and authorize global regulatory filings for new product launches,...bodies. + Demonstrated expertise in both US and international IVD regulatory frameworks. + Comprehensive understanding of… more
- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Regulatory Affairs Diagnostics. This position is a hybrid role and ... candidates from any location to apply. The Associate Director, Global Regulatory Affairs Diagnostics will provide an...product development. + Oversee the coordination and compilation of global submissions for (new) In Vitro Diagnostics ( IVD… more
- Kelly Services (Norcross, GA)
- …for medical devices, including in vitro diagnostics (IVDs). The role will support global regulatory compliance across US FDA, Health Canada, and EU Notified ... for a Principal, Regulatory Affairs (Transfusion).** Principal, Regulatory Affairs - IVD / Medical Devices...for new products and significant product modifications. * Develop global regulatory plans, advising on product classification,… more
- Caris Life Sciences (Tempe, AZ)
- …than yourself, Caris is where your impact begins.** **Position Summary** The Global Companion Diagnostics Specialist is a key contributor in the Translational ... and in vitro diagnostic product development lifecycle strategies to support global marketing authorizations. This includes clinical programs with focused attention… more
- Danaher Corporation (Miami, FL)
- …precision diagnostics for millions of people worldwide - and we're using our unmatched global scale and proven playbook to make it happen, from hospital labs to ... You will be responsible for driving strategic operational execution, ensuring regulatory compliance, and achieving key milestones for critical clinical studies in… more