Regulatory Affairs & Quality Manager

About the role

**Candidate MUST be a resident of Shanghai for regulatory reasons**

The RA/QA Manager is responsible for driving Vision RT's product licensing strategy in China, including domestic and import registrations, and for acting as Quality Representative for Vision RT Shanghai. Forming part of the China management team, the RA/QA Manager works closely with QRC, clinical, customer support and sales colleagues in China, the wider APAC region and at Vision RT headquarters in the UK to implement Vision RT's high quality standards and business strategy.

Key responsibilities will include  

• Lead quality management and regulatory affairs for Vision RT Shanghai’s activities related to its designation as Vision RT Ltd.’s China Agent, product licensing, and importation, distribution and post-market customer support of Class III medical devices:
• Act as management representative within Vision RT Shanghai’s Quality Management System, responsible for post-market surveillance, legal compliance, regulatory registration management and liaison with the city, provincial and national NMPA.
• Post-market surveillance:
• Handle and maintain customer complaints and other product defect reports in accordance with the QMS and regulatory requirements.
• Review post-market data for reportable complaints and trends and follow procedures for reporting to the manufacturer and NMPA.
• Prepare and submit annual self-inspection reports to the NMPA.
• Legal compliance:
• Manage adverse events and field actions, ensuring that they are reported in compliance with NMPA requirements.
• Ensure that accurate records of adverse events and field actions are maintained in accordance with the QMS and regulatory requirements.
• Regulatory registration management:
• Develop and implement product registration strategies for Vision RT’s portfolio of Class III medical devices made in China and the UK.
• Liaise with the foreign manufacturer to ensure all medical device licences are in place and maintained.
• Liaison with the city, provincial and national NMPA:
• Liaise with the NMPA in Shanghai, Beijing and national level to ensure all required medical device and facility licenses for Vision RT’s products and operations in China are in place and maintained.
• This role requires China and international travel.

Essential Skills & Experience       

• Minimum 5 years of experience in a China quality or regulatory role in medical devices.
• Mandatory: Experience with Class III medical devices. Strong background in NMPA regulatory requirements and ISO 13485. Experience leading audits and interacting with the NMPA.
• Technical skills and training
• NMPA regulations for Class III medical devices.
• Ability to use Microsoft Word, Excel and Outlook and confident in general computer usage.
• Excellent written and verbal communication skills in Mandarin (fluent) and English (minimum C1 level).
• Strong leadership, analytical thinking, and problem solving abilities.
• Excellent report-writing and presentation skills.
• Must be able to render clear and accurate judgements.

Desirable Skills & Experience        

• Bachelor’s degree or higher in Engineering, Biomedical Engineering, Quality Management, Life Sciences, or a related field.
• ISO 13485 and China GMP, GDP.