Regulatory Affairs Director

Job Summary

A company is looking for a Regulatory Affairs Director, Dx/CDx and Medical Devices, US.

Key Responsibilities

• Develop US regulatory strategy for designated programs and contribute to clinical development plans
• Act as the representative of the US regulatory team at the global regulatory team for designated projects
• Oversee Dx/CDx and Device related regulatory agency communications, submissions, and approvals

Required Qualifications

• Minimum BS with 10+ years, MS with 7+ years, or PhD/MD/PharmD with 5+ years of experience in the biotechnical or pharmaceutical industry
• 5+ years of experience in a Regulatory capacity with broad and in-depth regulatory knowledge
• Experience working with various Health Authorities, primarily FDA, to support diagnostic testing
• Sound understanding of drug and diagnostic development processes and regulatory requirements
• Recent experience with diagnostic testing to support clinical trials in all phases of study