About the Company
Our client is a global leading medical device company which focuses on surgical products including surgical imaging and related accessories. They are one of the market leaders in the field and they have a very strong pipeline in their big business plans as well! They are now looking for a Regulatory & Quality Assurance Manager to support their business and build up the team potentially. This would be a new headcount and new team for the business, you will have great potential to develop your career here with a strong product portfolio. Please apply if you are experienced in medical device RAQA functions.
About the Team
Reporting to the Head of Regulatory & Quality Assurance. Closely working with the engineering team, Sales & marketing team and external parties. You will manage the whole portfolio of Regulatory & Quality Assurance in Hong Kong.
About the job
As a Regulatory & Quality Assurance Manager, you will
- manage the whole product portfolio’s RAQA issues to meet the compliance requirements
- ensure all required documentation are prepared for the approval process
- make sure all quality management systems comply with global standards
- responsible to prepare regulatory materials for MDR, recall and adverse events
- responsible for medical device complaints regarding to the regulatory issues
- work closely with regional RAQA teams to implement new product registrations locally
- work cross-functionally in order to provide regulatory input for product development and improvement
- supports audit internally and externally (ISO 13485, MDSAP, etc.)
- maintain good relationship with internal and external parties such as distributors, commercial teams and service teams
Skills & Experience required
- bachelor’s Degree in Biomedical engineering or science related aspects
- at least 6 years of experience as regulatory affairs in medical device sector
- experienced in handling medical devices from europe or united state
- experienced in working across the APAC areas is advantageous
- excellent command in oral and written English, Mandarin and Cantonese
Interested parties, please apply directly with your current and expected salary. Feel free to reach out to Perry Chung at firstname.lastname@example.org for any questions you might have.