Senior Regulatory Affairs Specialist (Med Device) #HHL

RECRUIT EXPRESS PTE LTD

Loyang, Singapore
Up to $6,000; not specified; not specified pm
Handle regulatory submissions for medical devices
Hands-on experience with us fda submissions
Prepare product registrations and renewals
The role involves handling regulatory submissions for medical devices across US FDA, EU MDR, and ASEAN markets

Job Summary

  • The role involves handling regulatory submissions for medical devices across US FDA, EU MDR, and ASEAN markets.
  • Candidates will prepare and maintain product registrations, renewals, and variations while ensuring compliance with ISO 13485.
  • The position offers a salary up to $6,000 with working hours from Monday to Friday during office hours.

Matching Summary

Match Score: 85

The role involves handling regulatory submissions for medical devices across US FDA, EU MDR, and ASEAN markets.

Salary

Up to $6,000; Not specified; Not specified

Skills & Requirements

Must-have

  • Handle regulatory submissions for medical devices
  • Hands-on experience with US FDA submissions
  • Prepare product registrations and renewals
  • Support MDR/Vigilance reporting
  • Ensure compliance with ISO 13485

Nice-to-have

  • Familiarity with ASEAN regulations
  • Experience with EU MDR requirements
  • Support regulatory strategy for launches
  • Knowledge of global regulatory requirements

Key Requirements

  • Minimum degree in Life Sciences or related field
  • Minimum 4 years regulatory affairs experience in medical devices
  • Hands-on experience with US FDA submissions required

Work Rights

Not specified

Tailored Resume

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