comScoreTag
Job ref no.: CT3115413-01#5776

Regulatory Affairs Specialist

Cook Medical

Benefits
  • 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.

Responsibilities:

  • 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

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.

Interested parties please click Apply Now to submit your application. You are also welcome to visit our website for more information: www.cookmedical.com

All applications applied through our system will be delivered directly to the advertiser and privacy of personal data of the applicant will be ensured with security.

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