Director, CDx Regulatory Consultant

Responsibilities

We are representing a confidential life sciences organization seeking a Director-level CDx Regulatory Consultant to lead companion diagnostic strategy engagements for pharmaceutical, biotechnology, and diagnostic clients. In this remote role, you will apply deep expertise in IVD regulatory pathways, quality systems, and global marketing authorizations to guide clients through development, clinical trial enablement, approval, and lifecycle management of companion diagnostics.

You will serve as the regulatory subject matter expert for CDx programs, translating FDA, EU IVDR, and global requirements into practical strategies. Your work will include leading consulting engagements to develop integrated regulatory roadmaps, coordinating with therapeutic development teams and diagnostic manufacturers, and advising on clinical trial assay use including patient selection, investigational device determinations, and performance study obligations.

Key activities include directing preparation of global regulatory submissions (Q-Submissions, Pre-IDE packages, IDEs, PMAs, EU IVDR technical documentation), leading regulatory authority interactions, reviewing analytical validation plans and clinical performance study protocols, and applying quality system expertise throughout the product lifecycle. You will also generate new business opportunities, support proposal development and bid defense, lead client workshops, and mentor regulatory consulting staff.

What We're Looking For

Required qualifications:

• Bachelor's degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or related scientific discipline
• Minimum 5 years of consulting experience focused on IVD, companion diagnostic, clinical trial assay, or precision medicine regulatory affairs
• Minimum 7 years total experience in an in vitro diagnostic, companion diagnostic, pharmaceutical, or regulatory consulting environment
• Direct experience designing global regulatory and commercialization strategies for companion diagnostics and clinical trial assays, working with both diagnostic manufacturers/laboratories and pharmaceutical sponsors
• Strong written and verbal communication skills with ability to translate complex CDx regulatory requirements into clear, actionable recommendations
• Strong scientific and analytical skills for interpreting biomarker, assay validation, clinical performance, and diagnostic clinical trial data
• Demonstrated ability to solve complex regulatory, submission, and commercialization challenges with risk-based solutions
• Leadership and team-building skills to guide multidisciplinary teams across diagnostic development, regulatory, quality, clinical, laboratory, and commercial functions

Preferred:

• Master's degree or higher in life sciences, molecular diagnostics, regulatory affairs, public health, laboratory medicine, pathology, or related discipline
• RAC certification

How We Work With You

Our talent team at Get A Job.ai will review your application and conduct an initial screening to understand your background and career goals. If there is a strong match, we will submit your profile to our client for consideration. Please apply exclusively through Get A Job.ai—do not contact the client organization directly, as this is a confidential search managed by our recruiting team.

Pay

Compensation details will be discussed during the screening process based on your experience and qualifications.

Get A Job.ai is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all candidates regardless of race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.