Strategic Regulatory Lead for SaMD & QMS

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, 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.