Global RAQA Manager — Medical Devices

Hoper Recruitment Limited; Hong Kong; Presencial; HKD 900 000 - 1 200 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Regulatory Affairs

Quality Assurance

Regulatory submissions

Formação académica

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

Descrição da oferta de emprego

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.