Job ref no.: CT3129593-01#4292

Regional Regulatory Affairs Specialist, NESEA & ANZ (1-year contract)

Fresenius Kabi Asia Pacific Limited

Responsibilities:
  • Support Regional RA, VIGL and QA team with various Medical Devices Regulatory and allied Quality and Vigilance projects.
  • Compilation and consolidation, lifecycle management, product launch coordination, RA Intelligence, RA/QA IT tools/platform facilitation in interfacing with the country stakeholders.
  • Provide regulatory linked quality oversight of responsible MD portfolio, ensure quality compliance and crisis management are well coordinated and handled
  • Adapt Regional RA strategy & objectives and ensure compliance to internal and external regulatory expectations & needs
  • RA coordination on management of new and existing product registrations and variation management in the countries
  • Appropriate interfacing with relevant RA, MKT & BU stakeholders in Divisional, Regional levels
  • Monitoring/Tracking RA changes, trends, issues (as applicable)
  • Provide quality oversight (quality complaint statistics, KPIs) and coordinate product related issue and crisis management in Q topics (FSCA, field alerts, recalls, Technical Servicing)
  • Support any other special projects assigned by Supervisor
Requirements:
  • University graduate in Natural Science, Pharmacy, Medicine or Engineering
  • 1-2 years in Regional or sub-Regional or Country Regulatory & Quality function preferably in Medical Devices sector
  • Medical Device vigilance experience will be beneficial
  • Knowledge  of QMS, ISO 13485, GDWSP, Europe MDR/MDD
  • Excellent communication and interpersonal skills to work with people of different levels and cultures; self-driven, with good analytical & presentation skills and attention to detail
  • Fluency in spoken and written English, Mandarin and /or any other Foreign Language
  • May renew contract, depending on operation need
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More job information
Job ref no. CT3129593-01#4292
Salary
Job Function
Industry
Location
  • Wanchai
Employment Term
  • Contract
  • Full-time
Experience
  • 1 year
Career Level
  • Entry level
Education
  • Degree
Benefits
  • 5-day week
  • Dental plan
  • Flexible working hours
  • Gratuity
  • Medical plan