Head of Regulatory Affairs

Location: Boston, MA (Hybrid)
Company: Growth-Stage AI/ML Diagnostics & Digital Health Company
Company Size: 200-500 Employees

About the Company

We are a rapidly growing healthcare technology company developing innovative AI/ML-enabled diagnostic and Software as a Medical Device (SaMD) solutions that empower clinicians with actionable insights and improve patient outcomes. With a strong commercial foundation and an expanding product portfolio, we are entering a pivotal stage of growth and seeking an experienced regulatory leader to help shape our global regulatory strategy.

Position Summary

The Head of Regulatory Affairs will serve as the company's senior regulatory leader, responsible for developing and executing global regulatory strategies across a portfolio of AI/ML-enabled diagnostics, software products, and digital health technologies. Reporting directly to executive leadership, this individual will play a critical role in guiding regulatory strategy from product conception through commercialization while ensuring compliance across key global markets.

This position requires a strategic leader who can operate at both the executive and operational levels, partnering closely with Product Development, Data Science, Clinical Affairs, Quality, Engineering, and Commercial teams to bring innovative technologies to market.

Key Responsibilities

• Develop and execute global regulatory strategies for AI/ML-enabled diagnostic and SaMD products.
• Lead regulatory submissions and approvals, including 510(k), De Novo, PMA, IDE, Breakthrough Device, CLIA Waiver, and international registrations.
• Serve as the primary regulatory interface with FDA, Notified Bodies, Health Canada, MHRA, and other global health authorities.
• Provide strategic guidance on emerging regulatory frameworks related to artificial intelligence, machine learning, cybersecurity, software lifecycle management, and digital health.
• Partner cross-functionally with R&D, Clinical, Quality, Data Science, Engineering, and Product teams to ensure regulatory requirements are integrated throughout product development.
• Develop regulatory strategies supporting software updates, algorithm modifications, post-market surveillance, clinical validation, and real-world evidence initiatives.
• Build, lead, and mentor a high-performing Regulatory Affairs team.
• Support executive leadership, board presentations, investor diligence activities, strategic partnerships, and potential M&A evaluations.
• Monitor evolving regulatory requirements and assess business impact across global markets.
• Drive continuous improvement of regulatory processes, systems, and organizational capabilities as the company scales.

Required Qualifications

• Bachelor's degree in a scientific, engineering, or related discipline.
• 12+ years of Regulatory Affairs experience within medical devices, diagnostics, digital health, or SaMD.
• 5+ years of leadership experience managing and developing regulatory teams.
• Significant experience with FDA regulatory pathways, including 510(k), De Novo, PMA, IDE, and/or IVD submissions.
• Hands-on experience supporting AI/ML-enabled medical devices, software platforms, digital diagnostics, or clinical decision support technologies.
• Strong knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, EU MDR, IVDR, and global regulatory requirements.
• Proven track record of direct interactions with regulatory agencies and successful product approvals.
• Demonstrated ability to influence executive stakeholders and lead within a fast-paced, cross-functional environment.

Preferred Qualifications

• RAC certification.
• Advanced degree (MS, PhD, MBA, MPH, or equivalent).
• Experience with Breakthrough Devices, novel regulatory pathways, or first-of-kind technologies.
• Background in diagnostics, precision medicine, digital pathology, imaging AI, cardiovascular diagnostics, oncology diagnostics, or clinical software platforms.
• Familiarity with cybersecurity, AI governance, software lifecycle processes, and real-world evidence strategies.

Industry Background Requirements

We are specifically seeking candidates whose careers have been built within:

• Medical Devices
• In Vitro Diagnostics (IVD)
• Molecular Diagnostics
• Digital Health
• Software as a Medical Device (SaMD)
• Clinical Decision Support Software
• AI/ML-Enabled Healthcare Technologies
• Connected Medical Devices
• Healthcare Data and Analytics Platforms

Important Note

This is not a pharmaceutical or biotechnology regulatory leadership position.

Candidates whose experience is primarily focused on:

• Pharmaceuticals
• Drug Development
• Biologics
• Cell & Gene Therapy
• Therapeutics
• IND/NDA/BLA Submissions

without significant medical device, diagnostics, digital health, or software regulatory experience will not be a fit for this opportunity.

The successful candidate must possess a strong understanding of product-based regulatory pathways such as 510(k), De Novo, PMA, IVD, SaMD, and AI/ML regulatory frameworks, rather than traditional drug development pathways.

Leadership Profile

The ideal candidate is a strategic, business-oriented regulatory executive who thrives in growth-stage environments. They are equally comfortable discussing regulatory strategy with executive leadership and rolling up their sleeves to address complex regulatory challenges.

They will have experience scaling regulatory organizations within companies of approximately 200-500 employees and possess the ability to navigate ambiguity while supporting rapid innovation. This leader should be passionate about leveraging emerging technologies, including artificial intelligence and machine learning, to transform patient care.

Compensation & Benefits

• Competitive Base Salary
• Annual Performance Bonus
• Equity Participation
• Comprehensive Medical, Dental, and Vision Coverage
• 401(k) Program
• Flexible Hybrid Work Environment
• Generous PTO
• Professional Development Support
• Regulatory Certification and Continuing Education Assistance