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
Quality Management Systems Implementation (ISO13485)
You will bring the following
2+ Years’ Experience in Quality Assurance in the IVD Space (ISO13485)
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.