Clinical, Quality and Regulatory Affairs

Corin operates in the highly regulated medical device industry, so compliance to the specific country regulations is paramount to everything we do. Our people in this area predominately have qualifications and backgrounds in Biomedical Engineering, Life Sciences, Biological, Pharmaceutical, Healthcare or Medical Devices.

Key skill requirements include being highly organised, process driven, prepared to challenge the “status quo”, problem solver, comfortable working with and interpreting large amounts of clinical, validation, verification, quality and regulatory data and documentation. 

The Global Quality, Clinical and Regulatory Affairs function includes;

Quality who owns the global quality system which holds our standard operating procedures, work instructions, product drawings, job descriptions etc. Sterility and Validation of our products, services and machinery is also led through the Quality function.

Clinical Affairs are responsible for the clinical trials of all our products, they work closely with the Clinical Data team who evaluate the clinical data for use within our markets.

Regulatory Affairs embed the global regulations into the business, Vigilance manage any complaints and Post Market Surveillance (PMS) assess and gain feedback on how the products and services are doing once they reach the markets.