Regulatory Affairs Director, Dx/CDx and Medical Devices, US
BeOne Medicines(1 month ago)
About this role
The Regulatory Affairs Director, Dx/CDx and Medical Devices will lead a small US team to develop and implement regulatory strategies for diagnostics and medical devices to support clinical trials and marketing authorization. The role represents US diagnostic regulatory interests within global teams, oversees regulatory communications and submissions, and aligns diagnostic testing with therapeutic development plans. This position reports to the Executive Director, Global Regulatory Strategy and focuses on FDA interactions and regulatory policy for diagnostics.
Required Skills
- Regulatory Strategy
- Diagnostics
- Medical Devices
- Regulatory Submissions
- FDA Interactions
- Gap Analysis
- Clinical Trials
- Team Leadership
- Regulatory Documentation
- Stakeholder Management
Qualifications
- BS (10+ Years)
- MS (7+ Years)
- PhD/MD/PharmD (5+ Years)
About BeOne Medicines
beonemedicines.comBeOne Medicines, formerly BeiGene, is committed to developing innovative cancer medicines by partnering globally to serve patients everywhere.
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