Regulatory R&D Manager

Posted 16 October 2022
LocationGermany
Job type Permanent
Reference70211
Contact NameJosh Greaves

Job description

Senior R&D Manager

 

Introduction

A highly successful, global In-Vitro Diagnostics (IVD) Manufacturer, headquartered in Frankfurt, Germany is searching for a talented and experience R&D Manager. You will be responsible for R&D of their Assays and Reagents as well as working closely with Regulatory Affairs related to submissions and Design Control processes.

This role will offer you

  • The opportunity to join an established organisation with a broad product portfolio
  • Opportunity to be hands on involved in R&D as well as leading a team
  • Opportunity to report in to C-Level function

You will be responsible for

  • R&D Strategy and Managerial Activities
  • Review Project Deliverables & Ensure Timelines are Adhered to
  • Research & Development of Reagents & Assays in Product Portfolio
  • Ensure Regulatory Compliance Throughout R&D Process

You will bring the following

  • 5+ Years’ Experience in a Medical Laboratory Environment
  • Deep Understands of IVD Products (ISO13485, IVDD/IVDR, GMP, GLP)
  • EU & FDA Regulatory Submissions Experience / Exposure
  • Fluent German & English
  • PhD or Masters Educated

 

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