Senior Quality Assurance & Regulatory Specialist

Introduction

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.