Regulatory & Quality Leader for AI SaMD

EPM Scientific; Hong Kong; Sur place; HKD 1 000 000 - 1 800 000; Plein temps

Résumé du poste

EPM Scientific in Hong Kong seeks a Head of Regulatory & Quality Affairs to lead regulatory strategy and quality systems for AI-enabled medical software moving toward global markets. You will partner with founders and cross-functional teams to shape compliant product development.

The role requires proven FDA/SaMD experience, ISO 13485, IEC 62304, and a track record building QMS in startup or scale-up settings, with the ability to influence stakeholders and prepare for inspections and regulatory

Qualifications

• Proven experience with FDA-cleared medical devices and SaMD.
• Experience with FDA 510(k), De Novo submissions.
• Exposure to AI-enabled healthcare technologies.
• Strong knowledge of ISO 13485, Design Controls, IEC 62304.
• Experience in startup/scale-up healthcare tech environments.
• Ability to influence stakeholders cross-functionally.

Responsabilités

• Lead global regulatory strategy for AI-enabled medical devices and 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.

Connaissances

Regulatory strategy

Quality management

Cross-functional collaboration

Leadership

Startup experience

Description du poste

EPM Scientific in Hong Kong seeks a Head of Regulatory & Quality Affairs to lead regulatory strategy and quality systems for AI-enabled medical software moving toward global markets. You will partner with founders and cross-functional teams to shape compliant product development.

The role requires proven FDA/SaMD experience, ISO 13485, IEC 62304, and a track record building QMS in startup or scale-up settings, with the ability to influence stakeholders and prepare for inspections and regulatory