Director of Regulatory Affairs

A company is looking for a Director, Regulatory Affairs, Dx / CDx and Medical Devices.

Key Responsibilities

Develop and implement regulatory strategies for diagnostics and medical devices to support clinical trials and marketing authorization

Act as the representative for the European regulatory team in global discussions and provide oversight for regulatory documents related to diagnostics

Lead and mentor team members while maintaining knowledge of relevant laws and regulations across European regulatory authorities

Required Qualifications

Minimum of 10+ years' experience in the biotechnical or pharmaceutical industry with a bachelor's degree

Extensive experience in regulatory roles with a focus on medical devices and diagnostic development regulations

Experience working with Notified Bodies and Member State Health Authorities for diagnostic testing support

In-depth understanding of drug and diagnostic development processes and EU / UK regulatory requirements

Recent experience with diagnostic testing in clinical trials is mandatory