Title: Assistant Manager, Quality Assurance and Regulatory Affairs

Location: Hong Kong

Company Overview:

This company is a global leader in optical and digital precision technologies, with a history spanning over a century. It is recognized for its groundbreaking innovations in imaging, medical devices, and scientific instruments. The company’s product portfolio includes high-quality cameras, endoscopes, and microscope systems, which are used in a wide range of industries, including healthcare, life sciences, and imaging. Focused on improving quality of life, the company is dedicated to advancing technology that addresses both present and future challenges in various fields.

Position Overview:

This position is responsible for supporting the management of product development's quality and regulatory aspects to ensure regulatory compliance and quality requirements for the HK market needs. This role requires effective collaboration across Quality Assurance and Regulatory Affairs functions at the manufacturing entities, APAC regional offices and other related internal and external stakeholders.

Responsibilities:

Responsible for leading, evaluating and developing a local team of QA/RA executives and engineers to support various initiatives related to quality assurance and regulatory affairs, ensuring compliance with regulatory standards and customer requirements.

Quality Assurance

• Support in implementation and maintenance of quality management system policies, including ISOs, and procedures and ensure compliance with relevant international standards and regulatory requirements
• Supporting development of training and/or change management materials and activities to support new processes and procedures
• Manage the documents life cycle including, but not limited to, issuing templates, reviewing and revising documentation, and routing documents for approval and qualification
• Ensure integrity of all QA files for the purpose of efficient and timely retrieval of generated documents
• Assist in internal and external audit and inspections
• Manage post-market surveillance activities such as NC, CAPA, complaint, adverse events, FSCA activities and take actions, if necessary, to support closure of issues

Regulatory Affairs

• Coordinates and collects specific registration information with R&D, Manufacturing, Clinical and other applicable departments, as necessary to support registration requirements
• Review and provide feedback on documentation and supporting evidence to ensure applicable regulatory requirements are met
• Manage product registration, including change notification and renewal, for submission to regulatory authority and monitor the progress, status and timeline
• Maintain product registration record to ensure proper documentation and record filing
• Responsible to ensure that regulatory clearances are obtained in a timely manner in line with expected business plans and responds to potential submission deficiencies

Qualifications:

• Bachelor’s degree holder, major in sciences, medicine, engineering, pharmacy, microbiology or another relevant scientific discipline is preferred
• Minimum 5 years relevant experience in medical device regulatory, R&D, diagnostics, life sciences or biotech sector
• Possess logical and analytical mind in developing and maintaining SOPs collaboratively with various departments
• Strong multi-tasking and project management skills, with a keen attention to detail
• Highly perceptive in identifying issues and implementing effective resolutions
• Strong commitment to accuracy and delivering error-free performance in all tasks
• Experience with regulatory requirements across APAC, EU, and other major markets is highly preferred
• Willingness to serve and support both internal and external stakeholders effectively
• Effective communicator with strong interpersonal skills; hardworking, self-motivated, and proactive in keeping management informed
• Excellent command of written and spoken English and Chinese/Mandarin
• Strong computer skills and familiarity with company software (SAP, Salesforce, ESAS, and MS Office Suite)

What you need to do now:

Click “Apply Now” if you are interested to be part of the team!

Alternatively, send your latest CV to Kalpana.charles@linksinternational.com for confidential discussion of your career!