Vice President of Quality Assurance and Regulatory Affairs

4 days ago


Reston, Virginia, United States Hartmann Young Full time
Job Title: Vice President, Quality Assurance & Regulatory Affairs

Hartmann Young is collaborating with a US-based diagnostics organization to fill this key role.

Job Summary:

The Vice President of Quality Assurance & Regulatory Affairs will lead global regulatory and quality strategies, ensuring compliance with US and international regulatory bodies. This role requires a strong background in FDA and CE-marking submissions, as well as experience managing cross-functional teams.

Key Responsibilities:

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

Requirements:

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

Preferred Qualifications:

  • 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.

Location and Work Expectations:

  • The position is based on-site, with a minimum of 3-4 days per week in-office.

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



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