Director Quality Assurance & Regulatory Affairs

*Candidates must have hands-on regulatory submissions experience (510k, PMA, De Novo)

We're looking for an experienced Regulatory Affairs and Quality leader to build out and run the compliance backbone for a newly launched medical device organization. This person will own risk management strategy, lead the quality management system, and act as the company's primary point of contact with regulatory bodies — working closely with R&D, Clinical, and executive leadership to bring products to market and keep them there.

Responsibilities

• Set direction and strategy for organizational risk management
• Lead regulatory strategy and manage submissions through to clearance
• Own quality system compliance, documentation, and audit-readiness
• Partner cross-functionally with R&D, Clinical, and Operations to keep approvals on track
• Build and run post-market surveillance and monitoring processes

Requirements

• Minimum of Bachelor's degree with 8+ years in quality/regulatory functions within medical devices (Class II or III)
• Proven success securing FDA clearance (510(k) and/or De Novo pathways)
• Experience setting up and managing a QMS
• Strong cross-functional leadership and program management skills
• Hands-on experience with ISO 13485 and ISO 14971 compliance