Director, CDx Regulatory Consultant

📋 Description

• Subject matter expert in CDx, IVD regulatory strategy, assays, and global approval pathways.
• Develop integrated CDx regulatory strategies aligned with therapeutic goals and timelines.
• Advise on FDA, EU IVDR, and global regulatory expectations, including submissions.
• Lead prep/review of regulatory docs: FDA Q-Submissions, IDEs, PMAs.
• Guide analytical validation plans and clinical performance strategies.
• Partner with cross-functional teams across clinical ops, QA, labs, biostatistics, and commercial.

🎯 Requirements

• Bachelor’s degree in life sciences or related field; equivalent experience.
• 7+ years in IVD/CDx, pharma, biotech, or regulatory consulting.
• Minimum 5 years direct consulting on CDx, clinical trials, or regulatory programs.
• Global regulatory strategy experience for CDx and diagnostic products.
• Strong knowledge of FDA and EU IVDR requirements.
• Master’s degree preferred; RAC a plus.

🎁 Benefits

• Competitive compensation package based on experience, qualifications, and location.
• Opportunity to work remotely within the United States.
• Leadership role within a growing precision medicine and regulatory consulting environment.
• Opportunity to influence innovative diagnostic and therapeutic development programs.
• Exposure to global pharmaceutical, biotechnology, and diagnostic projects.
• Opportunities to mentor teams and expand regulatory consulting capabilities.