Quality and Regulatory Manager

London, United Kingdom

Description

1 in 2 people will be diagnosed with cancer in their lifetime. Today, Colorectal Cancer (CRC) is the second most common cause of cancer related deaths in the UK. However, if it is diagnosed early, the treatment is simple and effective with high survival rates. Odin Vision mission is to improve early detection and diagnosis of cancer in gastroenterology though artificial intelligence.

Our award winning technology has been developed by experts at University College London in conjunction with world renowned clinical opinion leaders at University College Hospital. We believe Odin Vision’s technology is set to revolutionize clinical practice and we are looking for smart and passionate people to join our team.

The Role

As a Quality and Regulatory Manager you will be responsible for implementing and maintain a quality management system to support CE and FDA regulatory approvals for our software products. This role reports directly to the CEO and the manager will work closely with the technical team and manage 3rd party partners. 
Artificial intelligence and machine learning are revolutionizing the healthcare sector. This role presents an exciting opportunity to work on the cutting edge of bringing that new technology into the hospital. The nature of the technology brings new quality and regulatory challenges. This role will suit someone with the ambition to become a leader in this emerging field.

Responsibilities

• Responsible for developing, implementing and maintaining a Quality management System.
• Manage audits from 3rd parties.
• Support/lead regulatory and quality strategy.
• Manage relationships and submissions to 3rd parties including ethics committees, MHRA ect.
• Ensure compliance with CE and FDA.

Requirements

• Experience working in quality management and regulatory affairs within a medical device organization.
• Experience working with software as a medical device. Experience of working with artificial intelligence is a bonus.
• A strong understanding of MDD and MRD.

Apply now at: