Director, CDx Regulatory Strategy & Global Submissions

Visa Hunt; Germany (OH); On-site; USD 150,000 - 210,000; Full time

Job summary

Precision Medicine Group is seeking a Director, CDx Regulatory Consultant to apply deep expertise in companion diagnostic regulatory strategy and IVD development. You will advise clients on FDA/EU IVDR requirements, analytical/clinical validation planning, and global submission pathways, coordinating across drug and diagnostic teams.

The role requires leading consulting engagements, developing integrated regulatory roadmaps, and mentoring staff while staying current on evolving regulatory trends

Qualifications

• Bachelor’s degree in life sciences or regulatory-related field; related experience considered.
• Minimum 5 years of consulting in IVD/ companion diagnostic regulatory affairs.
• Minimum 7 years in an in vitro diagnostic/regulatory consulting environment.
• Direct experience with diagnostic manufacturers and pharmaceutical sponsors.
• Strong written and verbal communication; ability to guide multidisciplinary teams.

Responsibilities

• Serve as CDx regulatory SME for strategic client program positioning and global submission pathways.
• Lead engagements to develop regulatory strategies, roadmaps, and milestone timelines.
• Collaborate with cross-functional teams to ensure CDx development aligns with regulatory expectations.
• Advise on regulatory requirements for use of assays in clinical trials and global performance studies.
• Prepare global regulatory submissions and supporting documentation for CDx programs.
• Manage client workshops and educational presentations on CDx regulatory topics.
• Mentor regulatory consulting staff to support scalable CDx/IVD capabilities.

Skills

CDx regulatory strategy

FDA regulations

EU IVDR

Regulatory submissions

Cross-functional leadership

Education

Bachelor’s degree in life sciences

Master’s degree in regulatory affairs

Job description

Precision Medicine Group is seeking a Director, CDx Regulatory Consultant to apply deep expertise in companion diagnostic regulatory strategy and IVD development. You will advise clients on FDA/EU IVDR requirements, analytical/clinical validation planning, and global submission pathways, coordinating across drug and diagnostic teams.

The role requires leading consulting engagements, developing integrated regulatory roadmaps, and mentoring staff while staying current on evolving regulatory trends