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Regional RA & QA Manager (Medical Device)

Job Title: Regional RA & QA Manager (Medical Device)
Contract Type: Permanent
Location: Hong Kong
Industry:
Salary: Discretionary bonus
Reference: 46882_1628426814
Contact Name: Patsy Cheung
Contact Email: patsy.cheung@kos-intl.com
Job Published: August 08, 2021 20:46

Job Description

  • New headcount
  • Rapid growing medical company

About our Client

Our client is a US medical device company with a long heritage in manufacturing topnotch medical devices and instruments. To cope with their global business expansion plan, they would like to invite a Regional Regulatory Affairs & Quality Assurance Manager to join their regional team.

About the Role

Reporting to the Director of Regulatory Affairs, you are responsible for regulatory affairs and quality assurance activities to assist in regulatory submission, registrations, listings, audits, and complaint handling on medical equipment for the Asia Pacific region. You will develop and execute regulatory strategies for new and established products by working closely with the global headquarters' regulatory affairs division. You will assure compliance with applicable medical equipment regulations per jurisdiction guidance and standards for local registrations. Additionally, you will keep abreast on the latest regulatory rules in Europe, United States and other Asian countries.

Requirements

  • Bachelor Degree holder in any Science related discipline
  • Minimum 5 years' medical device regulatory relevant experience working at a sizable medical device company, with regional exposure
  • Strong product regulations, enforcement and industry practice relevant to the medical device industry
  • Independent and a self-starter with the ability to make sound recommendations and decisions
  • Must be able to work in a multi-cultural environment
  • Proficient in spoken and written English is a pre-requisite for this role

Click "Apply Now" to apply for this position or call Patsy Cheung at +852 3180 4917 for a confidential discussion. All information collected will be kept in strict confidence and will be used for recruitment purpose only.