Vice President of Quality Assurance and Regulatory Affairs
4 days ago
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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