About our Client

Our client is a well-known medical device company and a leading company with a long heritage in supplying life saving surgical products to hospitals worldwide. A rare opportunity has arisen and they are now inviting a Head of Regulatory Affairs & Quality Assurance to join their regioinal team.

About the Role

Reporting to the Head of Business Operations and leading a regional regulatory affairs and quality assurance team, you are responsible for implementing regulatory affairs and quality assurance strategies to support business growth across the Asia Pacific region. You will develop and execute regulatory strategies for new and established products by working closely with country teams. You will assure compliance with applicable medical equipment regulations per jurisdiction guidance and standards for local registrations. Additionally, you will keep abreast on the latest regulatory guidelines and policies to ensure product registration efficiency.

Requirements

• Bachelor's degree holder in Science related disciplines
• Minimum 15 years' medical device regulatory affairs relevant experience working with medical device company, ideally with regional exposure
• Strong product regulations, enforcement and industry practice relevant to the medical device industry
• Independent and a self-starter with the ability to make sound recommendations and decisions
• Must be able to work in a multi-cultural environment
• Proficient in spoken and written Chinese and English is a pre-requisite for this role

Click "Apply Now" to apply for this position or call Patsy Cheung at +852 3180 4917 for a confidential discussion. All information collected will be kept in strict confidence and will be used for recruitment purpose only.