Regulatory Affairs and Quality Specialist

Posted 15 September 2022
Job type Permanent
Contact NameJosh Greaves

Job description

Senior Quality Assurance & Regulatory Specialist



A spin-off of one of the world’s largest In-Vitro Diagnostics (IVD) manufacturers, located in Berlin is currently searching for an experienced Quality Assurance & Regulatory Affairs Specialist to join their ever growing team after a successful merger.

This role will offer you

  • The opportunity to join a start-up environment, now heavily invested in by it’s parent company

  • Opportunity for growth in your career with role progression and education

  • Opportunity to work in a flat hierarchy

You will be responsible for

  • IVD Submissions According to EU Regulations (EU-IVDR)

  • Ensuring Regulatory Compliance to Appropriate Standards

  • Post-Market Surveillance Activities

  • Vigilance Reporting

  • Quality Management Systems Implementation (ISO13485)

You will bring the following

  • 2+ Years’ Experience in Quality Assurance in the IVD Space (ISO13485)

  • EU-Regulatory Submissions

  • Experience as Point of Contact for Notified Body

  • Education in Scientific / Engineering Studies


BioTalent Ltd are acting as an employment agency in relation to this opportunity.