Full-time – Medical Device Regulatory Affairs and QA specialist [RA]

The candidate will be part of the Governance, Risk and Compliance (GRC) team which leads all the actions related to compliance and quality within the ABL group.


Job Summary

  • This position will participate to gain approval of new products, new intended uses for existing products, and approval of existing products in new regions and changes to existing products.
  • The products are standalone softwares and reagents.


  • Have a minimum of 3-5-years of experience in a med-tech company or similar life-sciences organization.
  • Experience (user and implementer) with ISO 13485:2016 and EN ISO 14971:2012.
  • Other experience and knowledge related to quality standards used for medical devices is a plus.
  • Good knowledge and understanding of new (EU) regulations (2017/745 & 2017/746).


  • Fluent in spoken and written English.
  • Team player able to interact with multiple functional disciplines.
  • Task-oriented individual with a high-level of attention detail skills.