Regulatory Affairs Specialist Ii

Merit Medical

Maastricht, Netherlands
Global regulatory pathways
Product classification
Regulatory submission
At Merit Medical, our mission is to create innovative medical devices that improve lives

Job Summary

  • At Merit Medical, our mission is to create innovative medical devices that improve lives.
  • Assist with determining global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
  • A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work.

Matching Summary

At Merit Medical, our mission is to create innovative medical devices that improve lives.

Skills & Requirements

Must-have

  • global regulatory pathways
  • product classification
  • regulatory submission
  • international standards
  • Medical Devices Directive
  • Medical Device Regulation (MDR)
  • ISO 13485 Quality System

Nice-to-have

  • self-motivated
  • strong attention to detail
  • excellent time management
  • strong interpersonal skills
  • energetic and dynamic culture
  • supportive and collaborative environment

Key Requirements

  • Bachelor's Degree in biological, physical, engineering or health science disciplines
  • four years of related experience
  • Supervisory skills preferred
  • Demonstrated computer skills

Work Rights

Not specified

Tailored Resume

Cover Letter