Regulatory & Quality Lead, MedTech (HK)

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

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.