RAQA Manager (Global Top 5 MNC, Medical Device)

Hoper Recruitment Limited; Hong Kong; On-site; HKD 900,000 - 1,200,000; Full time

Job summary

We are seeking an experienced RAQA Manager for a global medical device player to lead regulatory and quality activities in Hong Kong. The role covers product listings, regulatory submissions, tender support, and post-market surveillance for imaging equipment and software.

The ideal candidate will have 5–8 years in RA/QA within medical devices, strong ISO knowledge, and experience with audits and CAPA. Proficiency in English and Chinese is required for cross‑border collaboration.

Qualifications

• Minimum 5-8 years of RA/QA experience in the medical device or regulated healthcare industry.
• Solid knowledge of ISO 13485, ISO 9001, ISO 14001 & ISO 45001.
• Experience in QMS, regulatory submissions, audits and CAPA.
• People-management experience preferred.
• Proficiency in written and spoken English and Chinese.

Responsibilities

• Local Listings & Compliance: Manage and execute product listings/registrations under MDACS for Imaging equipment and software; liaise with DH, local authorities and Hospital Authority.
• Tender Support: Provide regulatory documentation, compliance statements, and certification proof for government and private hospital tenders.
• QMS Management: Maintain and enhance local QMS per ISO 9001 and ISO 13485.
• Audit Readiness: Lead internal reviews and prepare for corporate, third‑party, and health authority audits.
• Post-Market Surveillance: Oversee FSCA, recalls, adverse event reporting, and modifications for imaging equipment.

Skills

Regulatory Affairs

Quality Assurance

Regulatory submissions

Education

Bachelor's degree or above in Life Sciences/Engineering or related discipline

Job description

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.

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.

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