Job ref no.: CT3115413-01#5776

Regulatory Affairs Specialist

Cook Medical

  • 5-day week
  • Dental plan
  • Education subsidies
  • Medical plan

The Regulatory Affairs Specialist is responsible for assisting Regulatory Affairs Manager to coordinate and handle regulatory affairs in Hong Kong and coordinate & manage timely Regulatory Submissions between local company and our own overseas manufacturers.


  • Coordinate and Manage timely Regulatory Submissions between local company and our own overseas Manufacturers.
  • Coordinate and implement the registration process for the company products
  • Act as a bridge between the legal bodies and the company.
  • Work with our manufacturers to provide strategy and multiple options for meeting regulatory requirements
  • Personally write and review regulatory submissions as needed
  • Organize electronic database (electronic library) of Regulatory Documents and government notifications on GTW (Global Technical Warehouse)
  • Create training documents to improve regulatory skills in Local office and other manufacturers
  • Train employees to improve regulatory skills in local office or region and at our manufacturers, where applicable
  • Negotiate with local authorities on behalf of Company objectives
  • Support reimbursement efforts for submissions when applicable
  • Represent the company as a member of industry organizations
  • Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements


  • Degree in Science, Engineering or any other related disciplines
  • 2 years of regulatory working experience in MNC, preferably in medical device or pharmaceutical industry
  • Experience in negotiating with regulatory authorities would be an advantage
  • Excellent organizational and interpersonal skills, positive working attitude and be a good team player.
  • Attend to details and able to work with limit supervision.
  • Able to work with both internal and external customers from different level
  • Fluent in English and Chinese, both written and spoken.

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More job information
Job ref no. CT3115413-01#5776
  • N/A
Job Function
Employment Term
  • Permanent
  • Full-time
  • 2 years
Career Level
  • Entry level
  • Degree