Head of Regulatory & Quality Affairs

About the role

Our client is an innovative healthcare technology company developing AI-enabled medical software solutions that aim to transform how clinicians diagnose and manage disease. As part of its next phase of growth, the company is seeking a Head of Regulatory & Quality Affairs to lead regulatory strategy, quality systems, and product commercialization activities as it progresses toward global market expansion. This position offers a rare opportunity to join at an early stage and play a foundational role in shaping both the regulatory framework and long‑term business success of the organization.

Key responsibilities

• Lead global regulatory strategy for AI‑enabled medical devices and Software as a Medical Device (SaMD).
• Drive FDA regulatory activities, including 510(k), De Novo, and other applicable pathways.
• Establish, maintain, and continuously improve Quality Management Systems (QMS) aligned to ISO 13485 and global regulatory requirements.
• Collaborate closely with founders, engineering, product development, clinical, and commercial teams.
• Ensure compliance with Design Controls, Risk Management, Software Lifecycle, Verification & Validation requirements.
• Support the transformation of research‑stage products into regulated commercial medical devices.
• Act as the key regulatory and quality representative for audits, inspections, and interactions with regulatory authorities.
• Build and lead the Regulatory & Quality function as the company scales.

Required profile

• Proven experience working on FDA‑cleared medical devices and/or SaMD.
• Experience with FDA 510(k), De Novo, or equivalent regulatory submissions.
• Exposure to AI‑enabled healthcare technologies, medical imaging, clinical informatics, digital health, or software‑driven healthcare products.
• Strong knowledge of ISO 13485, Design Controls, IEC 62304, Risk Management, and Quality Systems.
• Experience operating in startup, scale‑up, or innovative healthcare technology environments is highly desirable.
• Ability to work cross‑functionally and influence stakeholders across technical and commercial functions.

Required skills

• ISO 13485
• IEC 62304
• Design Controls
• Risk Management