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.

Contact
Zalika Ho
Quote job ref
JN-052022-5630324
Phone number
+852 3602 2400

Job summary

Function
Life Sciences
Specialisation
Regulatory Affairs
What is your area of specialisation?
Healthcare / Pharmaceutical
Location
Hong Kong
Job Type:
Permanent
Consultant name
Zalika Ho
Consultant phone
+852 3602 2400
Job Reference
JN-052022-5630324