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• 30 Sept 2026

  Senior RAQA Manager (Medical Device)

  Malaysia

  Permanent Position

  Multinational Company
  Job Description

  • Provide regional leadership across Regulatory Affairs and Quality Assurance, ensuring products and business activities comply with applicable regulatory and quality requirements across ASEAN markets.
  • Oversee product registration, regulatory submissions, renewals, variations, post-market requirements and other lifecycle activities.
  • Provide regulatory and quality guidance to country teams, commercial teams and partners.
  • Business Unit Growth: Build, launch, and scale the commercial strategy to sell our regional regulatory capabilities as a standalone service to global medical technology principals.
  • Revenue Generation: Serve as the primary technical point of contact to pitch, onboard, and retain third-party medical device clients navigating complex ASEAN regulatory entry.
  • Lead the development and expansion of the company's own house range of products, identifying product categories with strong market potential and strategic relevance.
  • Build a structured portfolio strategy covering product selection, positioning, pricing, market potential and country applicability.

  Expires on 30 Nov 2026

  Posted By

  Kimberley WAN

  Tel: 6011-11452271

  kimberleyjx.wan@peoplefirst.jobs

  apply now

  Requirements

  • Experience: 8–10+ years of progressive leadership experience in Regulatory Affairs, Quality Assurance, or Commercial Supply Chain Operations within the MedTech, Medical Device, or Healthcare Sourcing
  • Regulatory Expertise: Proven track record of successfully managing multi-country medical device registrations (GDPMD, ISO 13485) and dealing with regional regulatory authorities (e.g., MDA, HSA).
  • Experience working with medical consumables and/or OEM manufacturers.
  • Strong commercial acumen and the ability to translate technical and regulatory capabilities into marketable business propositions.
  • Mindset: An entrepreneurial "business-builder" mindset with the commercial polish required to pitch services directly to senior executive principals.
  • Education: Bachelor’s degree in Biomedical Science, Pharmacy, Supply Chain Management, or a related discipline. An advanced degree or professional regulatory certification is highly advantageous.