Regional Quality Assurance & Regulatory Affairs Specialist
Medical Devices Industry
Overseas training provided
About Our Client
A leading company specializing in wound healing. The organisation has been in the market for more than 100 years.
As Regional Quality Assurance & Regulatory Affairs Specialist you will be reporting to the Head of Asia & Middle -East, Quality Assurance & Regulatory Affairs. Your responsibilities will include but not limited to:
- Maintain the regional overview of country registration status and provide periodic status update as appropriate.
- Assist to establish regulatory and quality processes/procedures to enhance cross-departmental activities; expedite market access and business growth.
- Liaise with overseas partners pertaining to Regulatory Affairs activities, including product registrations, variations to existing products, renewals, etc.
- Managing compliance of products in accordance with existing regulations and guidelines.
- Timely compile and prepare regulatory documentation for submission to local authority.
- Update and maintaining all product registration license in the region and initiate renewal according to the country's stipulated timeline.
- Support audit activities by certification bodies.
- Ensure that all complaints requiring customer responses are properly addressed, as assigned.
- Work closely with inter-departmental personnel to ensure quality is maintained throughout the organization.
- Ensures timely investigation of and response to product complaints.
- Perform other duties or projects as assigned.
The Successful Applicant
The ideal Regional Quality Assurance & Regulatory Affairs Specialist that we are looking for should have:
- At least 2 years' experience in a QA/RA role handling medical devices.
- Possess fundamental knowledge in medical device registration in SEA countries.
- Can work independently as well as in a team with regional offices.
What's on Offer
- Continuous development and career advancement opportunities within the organisation.
- Overseas training is provided.