VP Regulatory Affairs & Quality Assurance
On-site · Flowery Branch, Georgia, United States
Job Summary
VP Regulatory Affairs & Quality Assurance leads global regulatory strategy across FDA, EU MDR, and international markets; drives product approvals, submissions, audits, and agency interactions; partners with commercial and product teams to accelerate market access and commercialization; serves as a senior advisor to clients, regulators, and executive stakeholders; oversees Quality Management Systems (QMS) and continuous improvement initiatives; builds and mentors a high-performing RA/QA organization; supports strategic growth initiatives, including partnerships and M&A due diligence.
Required Qualifications
- 15+ years of progressive Regulatory Affairs and/or Quality experience
- Deep expertise in FDA, EU MDR, ISO 13485, and global regulatory frameworks
- Strong executive presence with the ability to influence C-suite stakeholders and clients
- Proven success leading regulatory strategy in medical device, pharmaceutical, or life sciences industries
- Experience supporting commercialization and market expansion initiatives
- Passion for leadership, quality excellence, and strategic problem solving
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