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Being deeply inspired about developing hi-tech devices supporting medical science and about forming a passionate team.

Regulatory and Integration Specialist - medical device

About the position:

In this position You will be responsible for preparing the regulatory submissions required for the distribution of in vitro diagnostic devices (IVD) on the domestic and international markets. The position is expected to actively contribute to the development, implementation and management of procedures that ensure the product development process meets all regulatory requirements.


  • Active participation in creating and updating technical documentation for IVD product according to EU IVDR/ USA FDA requirements
  • Gap analysis between the documentation and related regulations, with suggestions for improvement
  • Compilation and submission of technical documentation required for registration
  • Cooperation with regulatory parties such as authorities, certification and notified body
  • Participation in product registration applications
  • Prepares and coordinates completion and filing of Post Market Surveillance documentation, Field safety Corrective Action, Adverse Event Reporting
  • Representing Quality/Regulatory on project teams throughout the product development cycle, providing feedback and guidance


  • College or university degree Experience in regulatory affairs within medical device (MD) or in-vitro medical device (IVD) industry
  • Proficient in English language (business professional level)
  • High precision
  • Good oral and written communication skills
  • Assertiveness
  • Ability to work independently
  • Open to embracing modern state-of-the-art technologies


  • Experience in the operation of the ISO13485 quality management system
  • Proficiency in audits by regulatory bodies such as notified bodies

What we offer

  • A long-term perspective
  • A team of young, ambitious and dynamic professionals offering exceptional support to enhance your talents and potential
  • Clear, flat hierarchy and a supporting company culture, quick feedback and short decision-making processes
  • Ability to grow together with the company
  • Extensive travel worldwide
  • Flexible work schedule

Working hours: Full time

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