Job ref no.: CT3114376-01#0426
One Arrow Consulting Asia Limited

Regulatory Affairs Specialist - Pharmaceutical / Medical Device

One Arrow Consulting Asia Limited

Job duties:

  • Responsible for all pre-market registration and ensure to complete all planned registration activities.
  • Efficiently communicate with regional and global team for all regulatory needs, submission preparation.
  • Provide regulation assessment for developing marketing strategy to support business growth
  • Pay attention on the regulation/policy announced by MDCO for monitor any impact to registration process or to facilitate any registration process
  • Responsible for all post-market actions, including labeling, PMA, Field Action, Tender support and Handle product incident report and develop complaint strategy to mitigate the compliance risk for Hong Kong and Hospital Authority & MDCO.

Requirement:

  • Bachelor degree or above
  • Health care related major is a plus.
  • Minimum 2 year relevant experience in health care industry
  • Proficiency in both spoken and written English.
  • Good interpersonal, writing and verbal communication skills required.
  • Be capable of prioritizing projects, dealing with multi-tasks, and delivering results on time.
  • Interact with internal/external business partners in a professional manner.
  • Knowledge of US and European regulations is a plus

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We regret that only shortlisted candidates will be notified or contacted.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

More job information
Job ref no. CT3114376-01#0426
Salary
  • N/A
Job Function
Industry
Employment Term
  • Permanent
  • Full-time
Experience
  • 2 years - 7 years
Career Level
  • Non-management level
Education
  • Degree
  • Master's degree