Quality Systems Specialist (IVDR)

Introduction

A young, family-run In-Vitro Diagnostic (IVD) manufacturer based in Berlin has recently been bought by a larger European IVD manufacturer, giving them the structure and injection of finances to grow and invest in their people. They are currently searching for an experienced and talented Quality Systems Specialist to join their team.

This role will offer you

• The opportunity to work with a highly talented, young and innovative team
• The chance to join an established and secure company with products successfully being sold on to the market
• A clear reporting structure with career development pathways

You will be responsible for

• Continuous development of company’s Quality Management System according to ISO13485 and IVDR
• Management of Complaint Management System and Change Deviations
• Oversee Internal / External and Notified Body Audits
• Planning and implementation of Risk Analysis (ISO14971)
• Developing in to role of Person Responsible for Regulatory Compliance (PRRC)

You will bring the following

• 2+ Years’ Experience in Quality Management Systems in the Medical Device / IVD space (ISO13485, MDR, IVDR)
• Good understanding of Internal / External Auditing process
• Good understanding of Manufacturing process within Medical Devices / IVD
• Good knowledge of both German & English

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