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• 03 Nov 2026

  Senior RAQA Specialist, APAC (Medical Device)

  Malaysia

  Permanent Position

  Global Medical Technology Company
  Job Description

  • Execute the regulatory strategy for obtaining registration approval of Intuitive’s portfolio, according to plan.
  • With limited supervision, coordinate with Distributor RA to compile regulatory documentation for submission to regulatory authorities, maintenance of licenses and change management.
  • Evaluate medical device changes, determine and execute regulatory strategy and ensure compliance.
  • Work closely with respective BU RAs to execute regulatory plans for medical device registrations in APAC indirect markets.
  • Communicate with Distributor RAs and Company's stakeholders (BU RAs, Commercial, PLO, PMO, Hardware Compliance etc.) to ensure compliance with the relevant medical device regulations in APAC indirect markets, including requirements for approval, change management and license renewals, while supporting business objectives.
  • Together with the Distributor RAs, determine the types of regulatory submissions or internal documentation required during new product submissions, change submission/variation/notifications etc.
  • Input and manage regulatory submission tracking information maintained in Intuitive’s regulatory database/systems (Veeva, PRDb, Agile, Smartsheet etc.).
  • Compile high quality submissions meeting technical requirements from regulatory authorities.
  • Perform periodic regulatory surveillance activities (e.g. new/upcoming regulations) and necessary impact assessments (RSA) using TrackWise.

  Expires on 03 Jan 2027

  Posted By

  Kimberley WAN

  Tel: 6011-11452271

  kimberleyjx.wan@peoplefirst.jobs

  apply nowview job details

  Requirements

  • 5 – 10 years of experience in medical devices registration in ASEAN countries.
  • Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook).
  • Fluent in written and spoken English.
  • Detail-oriented
  • Ability to multi-task, prioritize and schedule work to meet reporting or other deadlines.
  • Organizational and planning skills, including action orientation, focused urgency and driving for results.
  • Good team player, ability to collaborate and influence others.
  • Excellent interpersonal skills.