Medical Device Compliance Expert

3 days ago


Malmo, Skåne, Sweden g2 Recruitment Full time
Job Overview

g2 Recruitment is seeking a Regulatory Affairs Professional to join their team. As a Quality Engineer, you will be responsible for ensuring the quality and compliance of medical devices developed for drug delivery systems.

Main Duties:
  • Review and develop quality procedures and documentation.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  • Conduct risk assessments and support design control activities.
  • Maintain and review documentation for regulatory compliance.
  • Support audits and change management processes.

The ideal candidate will have a strong background in quality engineering and a passion for delivering high-quality solutions.

Qualifications:
  • Bachelor's degree in Engineering or a related field.
  • 3+ years of experience in quality engineering (medical device or pharma).
  • Knowledge of ISO 13485, FDA regulations, and risk management.
  • Excellent communication and problem-solving skills.


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