Regulatory / QA (Medical Device) HMS

RECRUIT EXPRESS PTE LTD

Islandwide, Singapore
Up to 6 k ph
Independent regulatory strategy guidance
U.s. fda 510(k) submission preparation
Eu technical files and design dossiers
The role involves providing independent regulatory strategy to enable timely and compliant product launches

Job Summary

  • The role involves providing independent regulatory strategy to enable timely and compliant product launches.
  • Candidates will prepare and submit premarket filings including U.S. FDA 510(k) and EU Technical Files.
  • The position requires monitoring evolving regulatory requirements to ensure continued market access.

Matching Summary

Match Score: 85

The role involves providing independent regulatory strategy to enable timely and compliant product launches.

Salary

Up to 6 k

Skills & Requirements

Must-have

  • Independent regulatory strategy guidance
  • U.S. FDA 510(k) submission preparation
  • EU Technical Files and Design Dossiers
  • Global medical device licensing submissions
  • Regulatory impact and gap analysis

Nice-to-have

  • Strategic planning support for product launches
  • Cross-functional stakeholder communication
  • Experience with Class I, IIa, and III devices

Key Requirements

  • Experience with FDA 510(k) submissions
  • Knowledge of EU Technical Files for medical devices
  • Ability to perform regulatory gap analyses

Work Rights

Not specified

Tailored Resume

Cover Letter