Senior Specialist, Global Commercial QA

Radiometer

York, United Kingdom

The Senior Specialist, Global Commercial QA for Radiometer is responsible for ensuring Standard work and QMS for Distributor and Subsidiary Management Globally for Radiometer.

This position is part of the Global Commercial RAQA located in Denmark and across globe and will be fully remote. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the Global Commercial QA team and report to the Manager, Global Commercial QA responsible for ensuring right level of QMS setup at Distributors and Subsidiaries. If you thrive in a multifunctional, DBS min, fast paced, supporting role and want to work to build a world-class Global Commercial QA organization read on.

In this role, you will have the opportunity to:

Owns and supports Distributor and Subsidiary Management QMS setup.
Perform Audits of Subsidiaries and Distributors
Manage Distributor Agreements (Track and manage Agreements)
Owns and supports the processes where RMED acts as a distributor.
Ensure trending of feedback from authorities for the purpose of improving processes

The essential requirements of the job include:

The preferred candidate holds a Master’s Degree, PhD, or Doctorate in Science, Engineering, Pharmacy, Biology, Biochemistry or the like.
Minimum of 10+ years of related work experience in Quality/Regulatory Affairs and/or directly supporting functions.
Detailed knowledge of EU MDD/MDR/IVD/IVDR requirements with experience in vitro diagnostics will be preferred
Experience in Auditing is an advantage
Experience with Distributor and Subsidiary Management