Head of Regulatory Affairs

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 Head of Regulatory Affairs 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

• Global Regulatory Strategy
• Global Product Submissions (EU-MDR, FDA, Japan, Brazil & Others)
• Design Control / Market Access Processes
• Management of Small RA Team (2023 Growth Plans)

You will bring the following

• 5+ Years’ Experience in Regulatory Affairs in the Medical Device Space
• EU-MDR & FDA Submissions Experience
• Quality Management Systems Implementation Experience
• Ideally Knowledge of IVDR Requirements
• Fluent English & Minimum B2 German

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