The RAQA Specialist act as the main point of contact for Medical Device Division (within the Hong Kong Department of Health). RAQA Specialist will be responsible for product registration and QA activities for Hong Kong, along with providing support on regulatory matters. The RAQA Specialist is also providing support to maintain the local Quality Management System (QMS) in compliance with the corporate global QMS and local regulatory requirements (if any).
The RAQA Specialist will provide support on other regulatory and quality assurance matters in South East Asia (SEA), as needed.
- Vigilance Activities – Complaint Handling, Adverse Event (AE), Field Safety Corrective Action (FSCA), Recall
- Assist on addressing product complaint from customer to manufacturer, monitor the status until closure
- Report Adverse Event (AE) to Global RA team
- Collaborate and work with Global RA team and local team on FSCA/Recall strategy and implementation
- Report the vigilance activities to Medical Device Division (MDD) in accordance to local regulation
- Labeling and Promotion Material
- Support Marketing team on the design of local in-country sticker, sleeve and IFU
- Review labeling and promotion material to ensure comply with corporate global and local regulatory requirements
- Supplier Management
- Support to manage outsourced services in accordance to corporate global and local requirements (qualification, evaluation, audit)
- Quality Assurance
- Support to maintain the local Quality Management System (QMS) in compliance with the corporate global and local regulatory requirements (if any)
- Support in preparing SOP and WI necessary to the organization
- Provide SOP training to employees
- Assist to perform internal audits to support compliance with applicable corporate global and local regulatory requirements
- Product registration, change, renewal
- Support regulatory functions through preparation, compiling and submission of all required regulatory documents to Medical Device Division (MDD)
- Filling of all regulatory submission documents in Global RAQA database on real-time basis
- Communication with Medical Device Division (MDD) for the questions and respond on timely basis
- Monitor regulatory submission timeline, follow up to ensure approval timeline on track
- Check the regulatory announcement and update on MDD website on regularly and keep updated of the new/revised regulatory requirements
- Prepare and submit regulatory report on a regular/monthly basis
- Updating of Global RAQA Database
- Any RAQA related tasks and/or projects assigned
This position reports to Associate RAQA Manager South East Asia (SEA) who reports to Senior RA/QA Manager Cluster.
Knowledge, Skills and Abilities:
- Complies with all company policies and procedures.
- Conducts self in a professional manner with customers, coworkers and management.
- Ability to communicate effectively in both written and oral form with all levels of management.
- Detail oriented and organized.
- Fluent in Cantonese and English.
- Computer literate, with intermediate skill in the use of Word, Excel and Outlook.
- Ability to work effectively either alone or as part of a team.
- Managing time effectively and completing tasks on time with minimal supervision.
- Office environment.
- Prolonged use of a computer.
- >3 years experience in Quality Assurance discipline
- 1 year experience in medical device regulatory submission in Hong Kong
- Experience in medical device regulatory submission in SEA will be an added advantage
- College Degree in a scientific or technical discipline
CVI Regulatory Affairs