Job Description

Position Summary

We are seeking a strategic and experienced Director of Global Quality and Regulatory Affairs to lead all quality and regulatory functions in support of our IVD (In Vitro Diagnostics) product portfolio and clinical laboratory operations. This role is critical to ensuring that our diagnostic products, processes, and systems meet global regulatory requirements, align with corporate objectives, and uphold the highest standards of quality and compliance.

The ideal candidate will bring deep expertise in regulatory frameworks related to IVDs and laboratory-developed tests (LDTs) , as well as hands-on experience in building and managing quality systems in regulated healthcare environments .

Key Responsibilities

• Lead global regulatory strategies and submissions for IVD products, LDTs , and other diagnostic solutions.
• Ensure compliance with applicable international regulations, such as: EU IVDR (In Vitro Diagnostic Regulation), FDA regulations (21 CFR Part 820, 812, 11), CAP, CLIA, ISO 13485, ISO 15189, and other applicable standards
• Oversee preparation of regulatory submissions and technical files, including CE marking and FDA pre-submissions.
• Lead the organization's transition to or maintenance of IVDR compliance, including performance evaluation plans, post-market surveillance, and notified body engagement.
• Maintain regulatory intelligence and guide internal teams on changes to applicable IVD regulations.
• Design, implement, and continually enhance a robust QMS tailored for IVD development and clinical laboratory operations .
• Ensure QMS compliance with ISO 13485, ISO 15189, IVDR, GxP, and CLIA/CAP standards.
• Oversee internal and external audits, non-conformance investigations, CAPA processes, and documentation systems.
• Promote a proactive quality culture and ensure readiness for regulatory inspections and certifications.
• Lead and grow a global team of quality and regulatory professionals across business units.
• Serve as the primary regulatory liaison with authorities, notified bodies, and third-party auditors.
• Partner with R&D, Clinical Affairs, Operations, Legal, and Commercial teams to ensure successful product development and lifecycle management.
• Provide executive-level guidance on regulatory risk, compliance planning, and go-to-market strategy for IVD products.
• Implement and maintain a comprehensive risk management framework aligned with ISO 14971.
• Lead risk assessments and updates, including FMEA reviews, when product or process changes occur.

Qualifications

• Bachelor's degree in a life science, engineering, or related field; advanced degree preferred.
• 9+ years of experience in regulatory and/or quality roles, preferably in the IVD, medical device, or diagnostic testing industries.
• Minimum 5 years in a senior management or leadership role.
• In-depth knowledge of regulatory standards and certification requirements
• Proven experience navigating regulatory submissions and inspections across U.S. and international jurisdictions

Preferred Skills and Certifications

• Prior experience leading IVDR implementation or supporting CE marking for IVDs.
• Demonstrated success in managing submissions such as FDA 510(k), or EU technical documentation.
• RAC (Regulatory Affairs Certification), ASQ Quality Certification, or Lean Six Sigma preferred.
• Strong leadership, communication, analytical, and cross-functional collaboration skills.
• Ability to manage remote, cross-regional teams in a fast-paced and evolving regulatory landscape.

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