Regulatory Affairs Manager

Hoper Recruitment Ltd.; Hong Kong; On-site; HKD 900,000 - 1,100,000; Full time

Job summary

Hoper Recruitment Ltd. is seeking a RAQA Manager for a leading medical device company in Hong Kong. You will manage Regulatory Affairs and QA, ensuring compliant listings and successful NPI launches across hardware and AI software.

Key responsibilities include HK MDACS listings, tender support, QMS maintenance, and audits. A senior professional with 8+ years in RA/QA within medical devices is preferred.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 8+ years in Regulatory Affairs and Quality Assurance in medical devices.
• Deep knowledge of Hong Kong MDACS requirements and local classifications.
• Experience in international regulatory frameworks (FDA, EU MDR/CE).
• Excellent stakeholder management in a matrix organisation.

Responsibilities

• Local Listings & Compliance: manage product listings/registrations under HK DH MDACS for imaging equipment and software, liaise with DOH, HA.
• NPI: collaborate with global teams to review dossiers for timely launches of hardware and AI/digital health software.
• Tender Support: provide regulatory docs and certifications for government and private tenders.
• QMS Management: maintain ISO 9001 and ISO 13485 compliant local QMS.
• Audit Readiness: lead internal reviews and preparations for audits.
• Post-Market Surveillance: oversee FSCA, recalls, adverse events, and modifications for complex imaging equipment.

Skills

Regulatory Affairs

New Product Introductions

Tender Support

Quality Assurance

Stakeholder Management

Education

Bachelor's degree in Life Sciences / Biomedical Engineering

Tools

MDACS

Job description

A multinational and well established medical device company is looking for a RAQA Manager to join their team.

• Regulatory Affairs
• 5 days, Global Top 5 MNC

Key Responsibilities

Regulatory Affairs (RA):

• Local Listings & Compliance: Manage and execute product listings and registrations under the Hong Kong Department of Health Medical Device Administrative Control System (MDACS) for Imaging equipment and software. Serve as the primary point of contact with the Department of Health (DH), local healthcare authorities, and the Hospital Authority (HA) regarding regulatory issues and tenders.
• New Product Introductions (NPI): Partner with global regulatory teams and local product managers to review technical dossiers, ensuring smooth and timely commercial launches of hardware and AI/digital health software applications.
• Tender Support: Provide critical regulatory documentation, compliance statements, and certification proof to support government (Hospital Authority) and private hospital procurement tenders

Quality Assurance (QA) & Compliance

• QMS Management: Maintain and continuously enhance the local Quality Management System according to ISO 9001 and ISO 13485 standards.
• Audit Readiness: Lead internal compliance reviews and spearhead preparation for corporate, third-party, and health authority audits.
• Post-Market Surveillance: Oversee the Field Safety Corrective Action (FSCA) process, handling product recalls, adverse event reporting, and technical modifications for complex imaging equipment.

Qualifications & Experience

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Electrical Engineering, or a related scientific discipline.
• Minimum of 8 years of professional experience in Regulatory Affairs and Quality Assurance within the medical device industry (experience with capital/ class II, III equipment).
• Deep, working understanding of Hong Kong MDACS requirements, local medical device classification, and international regulatory frameworks (FDA, EU MDR/ CE etc.).
• Proven experience thriving in an international, highly matrixed corporate environment.
• Outstanding analytical and data-driven approach to solving regulatory bottlenecks.
• Strong stakeholder management capabilities to bridge communication between local sales goals and global corporate compliance teams.
• High change-agility and ownership to handle complex issues with transparency and ethics.

(All personal data collected will be kept confidential and is for recruitment purpose only. Please limit your resume to professional history and contact details; do not provide unnecessary personal info.)