Head of Regulatory Affairs & Quality Assurance

Hong Kong Permanent
  • Leadership Role
  • Competitive remuneration packages

About Our Client

Our client is an well-established medical device company, aiming to improve the health of patients across the world through their high quality medical device.

Job Description

  • Manage the Regulatory Affairs departments ensuring resources and expertise are assigned to meet company goals, objectives and regulatory compliance. Provide ongoing coaching and feedback to develop the team for future Regulatory Affairs leadership in the region
  • Ensure personal and team compliance, QMS procedures, policies and relevant medical device standards and regulations
  • Provide expert opinions on technical and legal matters associated with the registration of products in the region to internal stakeholders
  • Liaise and collaborate with various stakeholders in relation to all regulatory issues
  • Facilitate communications between all stakeholders in order to get products registered in the region
  • Liaise with all relevant distributors worldwide to ensure information flow and understanding of current processes
  • Collaborate with regional leadership to support APAC focused business improvement activities
  • Ensure timely and accurate reporting of key performance indicators in support of the regulatory metrics
  • Maintain an excellent understanding of all medical device regulatory requirements
  • Ensure all quality, regulatory, compliance, and product-specific requirements are met
  • Perform any ad hoc duties as required

The Successful Applicant

  • Bachelor Degree in life science related disciplines
  • 10+ years of RA experience in Medical Device industry
  • Experience with the regulatory environments of other Asian markets is preferred
  • Allocates time and resources effectively and efficiently to achieve agreed outcome
  • Well-organised, Ability to work under pressure
  • Excellent verbal and written English and Chinese communications skills

What's on Offer

A competitive remuneration package will be given to the right candidate.

Zalika Ho
Quote job ref
Phone number
+852 2848 4783

Job summary

Life Sciences
Regulatory Affairs
Healthcare / Pharmaceutical
Hong Kong
Job Type:
Consultant name
Zalika Ho
Consultant phone
+852 2848 4783
Job Reference

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.