Regulatory Officer London, UK/Hybrid 

Odin Vision is a multi-award winning company that provides state of the art AI enabled software applications for endoscopic procedures to aid clinicians in the detection and diagnosis of disease, supporting higher quality care, improved patient outcome and better value for healthcare payers.  

We are excited to offer the opportunity to join our Regulatory team in an full-time Officer role. The applicant would be expected to support regulatory submissions to notified bodies and help guide the regulatory pathway and maintenance of our Medical Devices.

What you'll do: 

• Support the implementation and maintenance of the 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; 
• Collect and manage data, supporting requirements analysis and documentation, end user testing, verification and validation. 
• Log any non-conformities raised on the system 
• Maintain an 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 
• Support Vigilance Reporting and Field Safety Corrective Action 
• Support Post-Market Surveillance 
• Participate in risk management activities 
• Maintain a knowledge of the latest regulatory changes and communicate this with subject specialists

Qualifications

• Undergraduate degree 
• Qualification for the implementation of relevant regulatory standards 

Experience

• A minimum of five years working in the medical device regulatory industry
• Knowledge of UK, EU and USA regulatory pathways

Desirable for the role

• Worked on and achieved clearance of a Medical Device in the USA through a PMA, De Novo or 510(k)

At Odin Vision we believe that diversity is an important contributor to our success and long-term company goals. Diversity in our teams can contribute to innovations and creativity and increase our ability to cope with change. Odin Vision is committed to encouraging equality, diversity and inclusion among our workforce, and eliminating unlawful discrimination. The aim is for our workforce to be truly representative of all sections of society and our customers, and for each employee to feel respected and able to give their best. 

Regulatory Officer London, UK/Hybrid

Find out more:  

Follow Odin Vision on LinkedIn 

https://www.linkedin.com/company/14067058/ 

https://odin-vision.com/