Director of Regulatory Affairs

Spencer Rigby; Massachusetts; On-site; USD 180,000 - 240,000; Full time

Job summary

Spencer Rigby, partnering with a fast-scaling healthcare technology company, seeks a senior regulatory leader to own strategy for SaMD, drive FDA engagements, and shape how software products are designed, built, and maintained under regulatory controls.

You will collaborate with engineering to implement design controls, lifecycle documentation, and risk management, build a robust QMS, and ensure audit readiness and international filings.

Qualifications

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

Responsibilities

• Own regulatory strategy for SaMD from planning to submission.
• Lead FDA engagement as primary contact with regulatory bodies.
• Build and maintain QMS in line with FDA/ISO standards.
• Partner with engineering on design controls & lifecycle documentation.
• Manage quality processes including CAPA, nonconformance, and complaints.
• Drive audit readiness and continuous improvement.
• Maintain SOPs, document control, and quality records.
• Communicate risk clearly to leadership.
• Monitor regulatory landscape and update policies as needed.
• Support deployments and inquiries related to quality.

Skills

Regulatory strategy

FDA engagement

QMS management

ISO 13485

Software validation

Risk management

Documentation & controls

Leadership

Job description

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 companywide 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.

What You'll Do

• 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.

Requirements

• 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