Director, CDx Regulatory Consultant (Medtech)

TL;DR

Director, CDx Regulatory Consultant (Medtech): Advising pharmaceutical and biotechnology clients on regulatory strategy and global marketing authorization for companion diagnostics (CDx) and IVDs with an accent on FDA and EU IVDR compliance. Focus on designing integrated Rx Dx development roadmaps, directing global regulatory submissions, and managing lifecycle strategies for precision medicine assays.

Location: Remote, Germany

Company

hirify.global is a specialized consulting firm providing regulatory and strategic guidance for companion diagnostics and precision medicine.

What you will do

• Serve as the CDx regulatory subject matter expert to advise clients on global submission expectations and commercialization pathways.
• Develop integrated Rx Dx regulatory strategies aligning diagnostic development with therapeutic milestones and commercial objectives.
• Direct the preparation of global regulatory submissions, including FDA Q-Submissions, IDEs, PMAs, and EU IVDR technical documentation.
• Lead interactions with regulatory authorities and notified bodies, interpreting agency feedback and developing response strategies.
• Review and guide the development of analytical validation plans, clinical performance study plans, and diagnostic clinical protocols.
• Manage, mentor, and develop regulatory consulting staff to support a scalable CDx and IVD practice.

Requirements

• Bachelor’s degree in life sciences, molecular biology, genetics, regulatory affairs, or a related scientific discipline.
• Minimum 5 years of consulting experience with a primary focus on IVD, CDx, or precision medicine regulatory affairs.
• Minimum 7 years of total experience in an IVD, CDx, pharmaceutical, or regulatory consulting environment.
• Direct experience working with diagnostic manufacturers and pharmaceutical sponsors to design global regulatory strategies.
• Strong ability to translate complex regulatory requirements into practical, actionable recommendations.
• Must be based in Germany.

Nice to have

• Master’s degree or higher in life sciences or regulatory affairs.
• RAC certification.

Culture & Benefits

• Collaborative, client-focused consulting culture.
• Opportunity to lead multidisciplinary teams across therapeutic and diagnostic functions.
• Work in a professional environment advancing precision medicine capabilities.