RA&QA Manager (Surgical Device) | 人才服務辦公室

職位描述

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.