Job Title

Job Description

• 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.

• 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"

• 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