Senior Global IVD Regulatory Leader

RQM+; United States; On-site; USD 150,000 - 200,000; Full time

Job summary

A leading MedTech consulting firm is seeking a Vice President for IVD Global Regulatory Affairs to oversee regulatory and clinical strategies for IVD products across the US and EU. This senior role requires strong expertise in FDA and EU IVDR regulations, extensive leadership experience, and the ability to contribute to innovative regulatory solutions. The candidate will serve as the main technical authority for IVDs, lead complex client engagements, and mentor technical staff. Competitive compensation and professional growth opportunities are offered.

Qualifications

• Minimum 10 years’ relevant experience in clinical, technical, or regulatory fields.
• Minimum 5 years’ experience in IVDs design or clinical application.
• Extensive knowledge of In Vitro Diagnostic Regulations, particularly EU MDR/IVDR.

Responsibilities

• Serve as the technical authority for IVDs across US and EU markets.
• Lead complex IVD engagements for FDA and EU IVDR approval.
• Mentor and coach IVD consultants and project teams.

Skills

Technical leadership

Regulatory expertise

Clinical trials knowledge

Cross-functional collaboration

Business acumen

Education

Advanced degree in relevant sciences

University degree in relevant sciences

Job description

A leading MedTech consulting firm is seeking a Vice President for IVD Global Regulatory Affairs to oversee regulatory and clinical strategies for IVD products across the US and EU. This senior role requires strong expertise in FDA and EU IVDR regulations, extensive leadership experience, and the ability to contribute to innovative regulatory solutions. The candidate will serve as the main technical authority for IVDs, lead complex client engagements, and mentor technical staff. Competitive compensation and professional growth opportunities are offered.