IVD Product Specialist

Posted 31 August 2022
LocationMunich
Job type Permanent
Discipline RegulatoryMedical & Drug Safety
Reference65755
Contact NameJosh Greaves

Job description

In-Vitro Diagnostic (IVD) Product Expert

Introduction

A well -known Medical Device Notified Body located in Germany is looking for talented IVD Experts to join their global Product Expert & Audit team.

This role will offer you

  • Opportunity to work with a well known Medical Device and IVD Notified Body

  • Work daily with some of the largest IVD companies globally

  • Gain experience working with a wide range of IVD products

You will be responsible for

 

  • Evaluation of Quality Management Systems / Technical Documentation during Audits in In-Vitro Diagnostics Companies according to EU

  • Evaluation of Dossiers Related to Products in IVD

  • Regular Consultation Directly with Customers & Clients

  • Involved in Training of New Members of Team

You will bring the following

  • Minimum Bachelors in technical area

  • 3+ Years’ Experience in Technical Function in IVD Area (QA/R&D/Production/QC)

  • Good understanding of Quality Standards in the Medical Device/IVD space (ISO13485, ISO14971)

  • Fluent German & English

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