IVD product expert

Posted 17 November 2022
LocationCologne
Job type Permanent
Reference73512
Contact NameIsaac Murray

Job description

Introduction
An exciting opportunity has arisen to work for one of the world’s largest medical device notified bodies.

 

The role will offer you

  • fully remote working from anywhere within Germany
  • Extensive training courses
  • opportunity to work with a variety of different medical devices
  • opportunity to improve understanding of how IVD companies do things
  • flexible working hours

 

You will be responsible for

  • Conducting audits based on the IDVR regulations
  • Compiling reports and the audit documentation
  • Evaluating IVD products in accordance with European guidelines
  • Reviewing technical documentation of IVD products
  • Making decisions regarding certifications

 

You will bring

  • A minimum of a bachelors in an engineering or natural science discipline
  • minimum of 2 years of experience in development, production, quality
  • assurance, regulatory affairs or quality management of medical devices
  • Audit training is a plus
  • A good level of English and German
  • Local and international business trips between 20 to 60% per month