Associate Regulatory Manager
In this role, you have the opportunity to
- Implement and maintain the regular activities on existing HK & GBA approvals, and accelerate compliance to HK& GBA requirements, and meet performance target.
- Coordinate, review, and file new device registration/approvals and amendments to existing products for market access into HK, and further approval in GBA if needed .
- Communicates with relevant competent authorities, agents, distributors, and local sales offices to ensure the most efficient path to application approval.
- Advise local and international teams on the most expedient route to obtaining product licenses and ensure market access strategy is aligned with local and international marketing/sales requirements. To resolve any conflicts of strategy with marketing/sales strategies and determine the regulatory impact of such strategy on license approval timescales .
You are responsible for
- Provide strategic regulatory planning to fulfil business needs for HK & GBA;
- Have experience on handing MD listing and certification/ licensing for regulated products in Hong Kong, for example Irradiating Apparatus Licence and Type approval/acceptance certificate for products which can emit radiofrequency "RF"
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree or above, major in medical or engineer.
- 5+ years RA experience on Medical Device, and lead team complete product listing in HK is preferred
- A comprehensive understanding of HK medical device regulations,
- Experience on how to make registration strategy to successfully register different type of medical device in an efficient, effective, and compliant manner
- Ability to organize, negotiate, and lead team in strategic discussions with internal and external partner.
- Eager to continually achieve higher target both on quality and schedule.
- Communication and influence skill in daily to solve the problem, •
- Ability on fast learning, project management
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