RAQA Manager (Global Top 5 MNC, Medical Device)

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

• Team Leader/ Management role
• Regulatory Affairs, QA
• Global Top 5 MNC

Key Responsibilities

• 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.

• Tender Support: Provide critical regulatory documentation, compliance statements, and certification proof to support government (Hospital Authority) and private hospital procurement tenders

• 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 or above in Life Sciences, Engineering or another relevant discipline.

• Minimum 5-8 years of relevant RA/QA experience in the medical device or other regulated healthcare industry.

• Solid knowledge of ISO 13485, ISO9001, ISO14001 & ISO45001 and legislations / regulations relevant to medical device in Hong Kong & Macau.

• ISO13485 or ISO9001 Lead Auditor qualification.

• Experience in QMS, regulatory submissions, audits and CAPA.

• People-management experience is preferred.

• Proficiency in written and spoken English and Chinese.

(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.) EA No. 82726