Regulatory Affairs Manager

TOGL(Holdings)Limited is a diagnostics company focused on diseases of the gastrointestinal tract. Our current research and validation programme targets accurate and efficient triage of patients with symptoms of colorectal cancer (CRC). We are looking for proactive, experienced, focused, and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company. As we progress towards commercialising a test for CRC, we are looking for a Regulatory Manager to lead the development process through relevant regulatory pathways.

Responsibilities:

• Lead Regulatory Affairs activities for medical devices, in vitro diagnostic medical devices (IVDs), including software as an IVD (SaMD) and genomic diagnostic technologies.
• Develop, maintain and update Technical Documentation in accordance with EU MDR, IVDR and other applicable regulatory requirements.
• Support the development and implementation of regulatory strategies for new product development, product changes and lifecycle management.
• Prepare and maintain regulatory documentation including Technical Files, Risk Management Files, Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Biological Evaluation Reports (BERs) and associated technical documentation.
• Provide regulatory input throughout the product development lifecycle, ensuring compliance with design control, verifi