Senior Regulatory Affairs Specialist

Stryker

Taipei, Taiwan
Hybrid
Regulatory submission dossier compilation
Local health authority engagement
Regulatory classification evaluation
Help bring innovative medical technologies to patients by driving regulatory excellence across the product lifecycle

Job Summary

  • Help bring innovative medical technologies to patients by driving regulatory excellence across the product lifecycle.
  • In this role, you will shape registration strategies, navigate evolving regulatory landscapes, and ensure compliant, timely access to life‑changing devices.
  • Participate as a collaborative team member in cross‑functional discussions, audits, and inspections, providing regulatory guidance and timely responses.

Matching Summary

Help bring innovative medical technologies to patients by driving regulatory excellence across the product lifecycle.

Skills & Requirements

Must-have

  • Regulatory submission dossier compilation
  • Local health authority engagement
  • Regulatory classification evaluation
  • Regulatory change monitoring
  • Cross-functional team collaboration
  • Regulatory compliance management

Nice-to-have

  • Hybrid work flexibility
  • Timely market access facilitation
  • Regulatory strategy development
  • Marketing collateral compliance review

Key Requirements

  • Minimum bachelor’s degree in scientific or related field
  • Minimum 3 years regulatory affairs experience
  • Proficiency in spoken and written English and Chinese
  • Experience with regulatory or quality management systems
  • Experience engaging with local health authorities

Work Rights

Not specified

Tailored Resume

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