Head of RA

Posted 02 November 2022
LocationBerlin
Job type Permanent
Reference70866
Contact NameJosh Greaves

Job description

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.