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Senior Regulatory Affairs Professional

2 weken geleden


Amsterdam, Noord-Holland, Nederland Life Science People Voltijd
About the Job

We are recruiting for a highly skilled Regulatory Compliance Specialist to join our team at Life Science People. As a Lead Auditor for EU compliance, you will be responsible for conducting customer audits and ensuring our clients' medical devices meet the necessary regulatory standards.

Main Responsibilities

  • Conduct customer audits to assess compliance with EU regulations
  • Create comprehensive audit reports for customers
  • Develop and maintain relationships with key customers
  • Stay up-to-date with the latest EU regulations and guidelines

Essential Criteria

  • Bachelor's or Master's degree in a scientific or engineering field
  • A minimum of 4 years' experience in the Medical Device industry (experience working for a Notified Body is an asset)
  • Knowledge of MDR (2017/745) and IVDR (2017/746) requirements
  • Excellent communication and interpersonal skills

What We Offer

  • Opportunity to work with a leading Notified Body
  • Ongoing training and professional development