Director of Regulatory Affairs

Spencer Rigby has partnered with a fast-scaling healthcare technology company with validated science, real-world impact, and strong commercial momentum.

As the company scales that impact, it is building the team and systems to ensure rapid, high-quality execution within a regulated environment. You will own regulatory strategy, FDA engagement, and company wide quality systems, working hand in hand with engineering and software teams to shape how the company's FDA-regulated products are designed, built, and maintained. You will influence product decisions from the outset, defining what is in scope for a submission, how changes are managed, and what documentation and controls are required across the software lifecycle.

• Own regulatory strategy. Lead end-to-end regulatory strategy for the SaMD platform, including future 510(k) submissions and international filings.
• Lead FDA engagement. Serve as the primary point of contact with the FDA and other regulatory bodies.
• Build the quality system. Lead and maintain the Quality Management System (QMS) in compliance with FDA, ISO 13485, and related standards.
• Partner with engineering. Ensure design controls, software lifecycle documentation, and validation processes meet regulatory requirements.
• Manage quality processes. Own CAPA, nonconformance investigations, and complaint handling.
• Drive audit readiness. Oversee internal and external audits, maintaining a constant state of audit readiness.
• Own documentation and controls. Establish and maintain SOPs, document control, and quality records.
• Communicate risk. Prepare risk assessments and surface regulatory risks clearly to leadership.
• Track the landscape. Monitor the evolving regulatory landscape and update policies and procedures as requirements change.
• Support deployment. Support clinical site deployments and customer quality inquiries.

• 10+ years of experience in regulatory affairs and/or quality within medical devices, digital health, or SaMD
• Direct experience leading FDA 510(k) or De Novo submissions for software or AI/ML-based devices
• Hands-on experience building or maintaining a QMS under ISO 13485 and FDA regulations
• Strong understanding of design controls, risk management (ISO 14971), and software validation
• Proven ability to translate complex regulatory requirements into clear guidance for engineering and product teams
• Experience managing CAPA, nonconformance, and audit processes
• Excellent written and verbal communication skills
• High ownership, strong follow-through, and sound judgment
• Comfortable operating as a lean team; resourceful and self-directed