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Jobs or company...

VP Quality Assurance & Regulatory Affairs, Diagnostics - US

Salary undisclosed

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Hartmann Young is working retained with a US-based diagnostics organisation, please see below for more details:

Job Description: Vice President, Quality Assurance & Regulatory Affairs

The Vice President of Quality Assurance & Regulatory Affairs will report directly to the CEO and is responsible for providing leadership and executing global regulatory and quality strategies across neurodiagnostic product lines. The ideal candidate will have significant experience with FDA and CE-marking submissions for medical devices, in vitro diagnostics, and software-based medical products. The role involves managing cross-functional teams and ensuring compliance with both U.S. and international regulatory bodies.

Key Responsibilities:

Regulatory and Quality Leadership:

  • Define and lead global regulatory and quality strategies and operations.
  • Oversee regulatory submissions, post-market surveillance, and audits.
  • Manage communication with regulatory agencies and ensure compliance.

Process & Compliance Management:

  • Establish processes supporting laboratory quality systems for commercial and research testing.
  • Lead efforts to transition products from laboratory-developed tests (LDT) to Medical Device/In Vitro Diagnostics classifications.

Collaboration & Oversight:

  • Work closely with R&D, quality, laboratory operations, and executive teams to maintain high-quality standards.
  • Oversee external regulatory and quality consultants to achieve strategic goals.

EU & International Market Strategies:

  • Develop regulatory strategies for product commercialization in the EU, Canada, Mexico, and other international markets.
  • Ensure compliance with EU MDR/IVDR requirements, and maintain technical documentation for CE marking.
  • Interface with notified bodies on product changes and lead technical audits.

U.S. Market Compliance:

  • Develop short- and long-term regulatory strategies for FDA submissions (Q-submissions, 510(k), PMA).
  • Collaborate with laboratory and quality leaders to ensure compliance with CLIA, CAP, and other certification bodies.
  • Stay current with FDA guidance for in vitro diagnostic products and laboratory-developed tests.

KeyRequirements:

Experience:

  • 12+ years in regulatory and quality roles within medical device or diagnostics companies.
  • Proven expertise in managing FDA and European regulatory submissions and audits.

Skills:

  • Strong project management, problem-solving, and leadership abilities.
  • Technical knowledge of FDA-IVD, CMS, EU-IVDR, and ISO standards.
  • Excellent communication skills, both written and verbal, with a hands-on approach.

Education & Certifications:

  • Bachelor's degree in a science-related field.
  • RAPS and ASQ certifications required, with ongoing professional development support.

Location & Work Expectations:

  • The position is based on-site, with a minimum of 3-4 days per week in-office, and candidates must be willing to work from the headquarters. Candidates from markets with direct flight access may also be considered.

This role requires adaptability, leadership, and a comprehensive understanding of the regulatory landscape for neurodiagnostic products.

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