We are excited to offer the opportunity to join Odin Vision’s exciting and friendly team as our Regulatory Manager, working closely with all departments within the company.

As a Regulatory Manager, you will have ownership of Odin Vision’s regulatory submissions. 

You will work with the Product Team to complete technical and regulatory documentation in line with documented standards to implement important design changes and releases for our medical devices on the UK, EU and US market.

You will receive training on the use of artificial intelligence in endoscopy to better detect the early stages of digestive cancer. 

Responsibilities

A Regulatory Manager shall carry out the following list of non-exhaustive activities: 

  • Implement and maintain a quality management system to support CE and FDA regulatory approvals for the Company’s software products, this includes, but is not limited to, interacting with auditors, notified bodies, EUAR, end users, patients and external consultants;
  • Creating and implementing Regulatory strategy 
  • Collect and manage data, supporting requirements analysis and documentation, end user testing, verification and validation.  
  • Log any non-conformities raised on the system
  • Work with the project lead to ensure all employees are trained and competent
  • Maintain up to date register of labelling
  • Author and maintain technical files in an organized and searchable way
  • Authorize and issue documents 
  • Periodically assess the contents of the Design History File 
  • Responsible for Vigilance Reporting and Field Safety Corrective Action
  • Responsible for Post-Market Surveillance 
  • Defining risk management processes and participate in risk management activities
  • Keep up with the latest regulatory changes

Qualifications

  • Undergraduate Degree
  • Qualifications for the implementation of relevant regulatory standards
  • A minimum of five years working in the medical device regulation industry
  • Working knowledge for the UK, EU and USA regulatory pathways