Head of Regulatory & Quality Affairs

Job Advertisement: Head of Regulatory & Quality Affairs

Location: Hong Kong

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.

Key Requirements:

• Proven experience working on FDA-cleared medical devices and/or Software as a Medical Device (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
• 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.

Why Consider This Opportunity?

• Foundational leadership role.
• Opportunity to shape regulatory strategy from an early stage.
• Significant influence on product development and company direction.
• Exposure to cutting-edge AI healthcare technologies.
• Career progression toward executive leadership as the company scales.

If you are interested in this role, please apply with your most updated CV attached.

Contact: Alvin Yeo Zong Han (Lic No: R24126316 / EA No: 16S8194)

Phone Number: +65 6027 2671