Director, CDx Regulatory Strategy & Compliance

Precision Medicine Group; Northern (KY); Hybrid; USD 162,000 - 243,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance and disability benefits

Parental leave

Paid time off for sick leave and VAC

Job summary

Precision Medicine Group seeks a Director, CDx Regulatory Consultant to apply deep expertise in companion diagnostic regulatory strategy, IVD development, and global marketing authorization pathways to advise pharmaceutical, biotechnology, and diagnostic clients on development, approvals, and lifecycle management of companion diagnostics.

This role translates FDA, EU IVDR, and other regulatory requirements into practical strategies that support Rx Dx co-development, patient selection assays,

Qualifications

• Minimum 7 years in in vitro diagnostic or regulatory consulting.
• Experience with FDA and EU IVDR regulatory requirements.
• Ability to translate complex CDx regulations into practical recommendations.
• Strong written and verbal communication and leadership skills.

Responsibilities

• Lead CDx regulatory engagements with pharmaceutical clients.
• Develop global regulatory strategies and submission roadmaps.
• Coordinate with cross-functional teams across development and commercialization.
• Direct global regulatory submissions and interactions with authorities.

Skills

Regulatory consulting

CDx / IVD knowledge

Regulatory strategy

Cross-functional leadership

Client advisory

Education

Bachelor’s degree in life sciences

Master’s degree in life sciences

Job description

Precision Medicine Group seeks a Director, CDx Regulatory Consultant to apply deep expertise in companion diagnostic regulatory strategy, IVD development, and global marketing authorization pathways to advise pharmaceutical, biotechnology, and diagnostic clients on development, approvals, and lifecycle management of companion diagnostics.

This role translates FDA, EU IVDR, and other regulatory requirements into practical strategies that support Rx Dx co-development, patient selection assays,