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Regulatory Affairs Specialist

Regulatory Affairs Specialist

OutsizedMalaysia, Malaysia
11 hours ago
Job description

Outsized is building a network of Regulatory Affairs professionals within the medical technology and healthcare sectors. As clinical trials and product innovation accelerate across the region, we are connecting specialists who can help global and regional firms navigate complex approval processes and regulatory frameworks.

Who We’re Looking For

We want to engage experienced Regulatory Affairs professionals who have supported the registration, compliance, and approval of medical devices, diagnostics, and digital health products across multiple markets.

Typical Experience Includes

  • Preparing and managing technical documentation for global and local submissions (FDA, CE, TGA, HSA, etc.).
  • Supporting end-to-end product registration and approval processes across Asia-Pacific.
  • Collaborating with Quality, Clinical, and R&D teams to ensure compliance from design to market release.
  • Monitoring and interpreting changing regulatory requirements across countries.
  • Managing audits, product variations, and post-market surveillance.

Ideal Background

  • Degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related field.
  • 5+ years’ experience in Regulatory Affairs within the medical device or MedTech industry .
  • Proven track record of managing multi-country submissions.
  • Strong understanding of ISO 13485, MDR / IVDR, and related frameworks.
  • Why Join the Outsized Network

  • Access exclusive opportunities with leading MedTech firms across APAC.
  • Be considered early for contract and permanent roles as projects go live.
  • Join a vetted pool of specialists shaping the future of healthcare and technology in the region.
  • Referrals increase your chances of interviewing at Outsized by 2x

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    Regulatory Specialist • Malaysia, Malaysia

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