Head of Regulatory & Quality Affairs

Job Description

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 13485Design ControlsIEC 62304Risk ManagementQuality SystemsExperience 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 Show More