Director, CDx Regulatory Consultant

Qualifications: Minimum Required: Bachelor’s degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a related scientific discipline; equivalent relevant experience may be considered. Minimum 5 years of applicable consulting experience with a primary focus in IVD, companion diagnostic, clinical trial assay, or precision medicine regulatory affairs. Other Required: Minimum of 7 years of experience in an in vitro diagnostic, companion diagnostic, pharmaceutical, or regulatory consulting environment. Direct experience working with diagnostic manufacturers/labs and pharmaceutical sponsors to design global regulatory and commercialization strategies for companion diagnostics and clinical trial assays. Strong written and verbal communication skills, with demonstrated ability to translate complex CDx regulatory requirements into clear, practical recommendations for clients and cross-functional teams. Strong scientific and analytical skills, including the ability to interpret biomarker, assay validation, clinical performance, and diagnostic clinical trial information in support of CDx regulatory strategy. Ability to solve complex CDx regulatory, clinical trial assay, submission, and commercialization challenges with practical, risk-based solutions. Strong leadership, team building, and interpersonal skills, including the ability to guide multidisciplinary teams across diagnostic development, therapeutic 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 a related discipline. RAC certification Any data provided as a part of this application will be stored in accordance with our . For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com . Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action.