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
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