Regulatory Affairs and Quality Specialist

Our client is a global leader in medical technology, committed to delivering safe and effective solutions that improve patient outcomes. They are expanding their Hong Kong team and seeking a Regulatory & Quality Compliance Specialist to strengthen compliance and quality assurance for their service center operations.

Role Overview

The successful candidate will be responsible for implementing and maintaining quality compliance and assurance activities, ensuring adherence to Hong Kong regulatory requirements and global standards.

Key Responsibilities

• Establish and maintain distributor and importer quality systems in line with Hong Kong Code of Practice.
• Ensure proper control measures for ordering, supply, and distribution of medical devices.
• Apply for and maintain licenses and permits ( Wholesale Dealer Licence, Dangerous Goods, Psychotropic Drugs).
• Support audits and inspections, implement corrective actions, and ensure HK GDP compliance.
• Monitor legislative updates (CAP 134, CAP 138, CAP 137) and update SOPs/WIs accordingly.
• Manage nonconformance, CAPA plans, and effectiveness checks.
• Oversee document control, electronic records, and SAP quality notifications.
• Conduct internal and external audits, including third-party distributors.
• Organize quality training and maintain regulatory reference libraries.

Qualifications

• Bachelor's degree in Pharmacy (Hong Kong) or equivalent science disciplines
• Minimum 3 years experience in Quality Assurance within pharmaceuticals or medical devices.
• Experience with ISO 9001, ISO 13485, and/or GDP standards.
• Hong Kong Registered Pharmacist highly preferred.
• Strong analytical, problem-solving, and communication skills fluent in English and Cantonese/Mandarin.

Why Join Us

• Be part of a global healthcare leader committed to quality and patient safety.
• Drive compliance excellence and make a tangible impact on healthcare delivery.
• Enjoy a collaborative culture with clear career progression opportunities.

Ready to Make an Impact
Apply now or send your latest CV to [Confidential Information] for a confidential discussion about this exciting opportunity in Hong Kong's healthcare market.