R&D Compliance Engineer

Nipro Europe Group

Mechelen, Flanders, Belgium
Full-time
Posted June 06, 2026

Job Description

You will be working in a team that ensures product compliance with relevant standards and Nipro's design and development process. This role is crucial in fostering a culture of design for compliance and quality, supporting continuous improvement, and ensuring the safety and regulatory compliance of our medical devices. You will collaborate with cross-functional teams to support the development of innovative and compliant medical devices that positively impact patient outcomes.

What you’ll do

Design Compliance (40%)

  • Ensure product compliance with applicable standards and regulations.
  • Prepare and maintain technical documentation according to MDR requirements.
  • Documentation Control (10%)

  • Maintain Design History Files (DHF) and controlled documents.
  • Collaboration and Co-ordination (20%)

  • Collaborate with cross-functional Nipro teams in EMEA and Japan.
  • Interface with contract developers and manufacturers in Eur...