Senior CDx Regulatory Strategy Lead

Precision For Medicine; Frederick (MD); On-site; USD 162,000 - 243,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision for Medicine seeks a Director-level CDx Regulatory Consultant to guide global regulatory strategies for companion diagnostics and clinical trial assays. You will translate FDA, EU IVDR, and other requirements into practical plans, working with pharmaceutical and diagnostic clients to enable regulatory approvals and lifecycle management.

The role emphasizes leadership across cross-functional teams, development of submission roadmaps, and engagement with regulatory authorities.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Minimum 5 years consulting experience in IVD/CDx or regulatory affairs.
• 7+ years in in vitro diagnostic/regulatory consulting environment.
• Experience with global regulatory submissions (FDA, EU IVDR).
• Ability to translate complex regulatory requirements into actionable recommendations.
• Strong written and verbal communication across cross-functional teams.

Responsibilities

• Serve as the CDx regulatory subject matter expert for strategic positioning of client programs.
• Lead consulting engagements to develop global CDx regulatory strategies and submission pathways.
• Partner cross-functionally with therapeutic development teams to align CDx activities with program timelines.
• Advise on regulatory requirements for use of assays in clinical trials and regulatory submissions.
• Direct preparation of global regulatory submissions and documentation for CDx programs.
• Lead interactions with regulatory authorities and notified bodies.

Skills

Regulatory strategy

Leadership

Communication

Cross-functional collaboration

Analytical skills

Education

Bachelor’s degree in life sciences

Master’s degree (preferred RAC)

Job description

Precision for Medicine seeks a Director-level CDx Regulatory Consultant to guide global regulatory strategies for companion diagnostics and clinical trial assays. You will translate FDA, EU IVDR, and other requirements into practical plans, working with pharmaceutical and diagnostic clients to enable regulatory approvals and lifecycle management.

The role emphasizes leadership across cross-functional teams, development of submission roadmaps, and engagement with regulatory authorities.