RA&QA Manager (Surgical Device) | HK Talent Engage

Job description

About Our Client

Our client is an international market leader in the medical industry. To cope with their further expansion in APAC, they would like to invite a high calibre individual to join their professional team as a Quality Assurance and Regulatory Affairs Manager.

About the Role

• Leading the QA/RA department to ensure quality excellence in accordance with local compliance and regulatory standards
• Coordinates R&D and clinical activities in accordance with specific registration information
• Oversees product registration as per design changes and renewal, and to closely liaises with regulatory authority on regulatory affairs
• Manage document life cycle and integrity of QA files for efficient record-keeping and retrieval
• Support internal and external audit and inspections
• Drive post-market surveillance such as CAPA, NC, and FSCA activities. Work with other departments in case of product issue management, and to ensure that regulatory clearances are obtained in a timely manner
• Perform ad-hoc activities as per urgent decisions

The successful applicant

• Bachelor degree in clinical science, engineering, pharmacy or other relevant disciplines
• A minimum of 8 years of experience in medical device regulatory, R&D, diagnostics, life science or biotechnology sector
• Analytical, attentive and organized with good problem-solving and project-management skills, able to facilitate communication across different departments
• Candidate with knowledge in APAC, EU and other regulatory compliance would be of great advantage, Candidate with experience in RA/QA management would be of advantage
• Candidates with less experience would be consider as Senior RA/QA executive

Click "Apply Now" to apply for this position or call Stanley Leung at +852 3180 4931 for a confidential discussion. All information collected will be kept in strict confidence and will be used for recruitment purpose only.