Mairi MacFadyen

Chief Regulatory Officer

A head and shoulders picture of Mairi MacFadyen, Director of Regulatory and Quality

Mairi joined Emblation in 2018 and is responsible for regulatory and quality system compliance in support of global market requirements. She has more than 25 years’ experience in the medical devices sector, working mainly in senior quality and regulatory management roles.

During her career she has been involved in devising regulatory strategies and preparing documentation for achieving market approval for a wide range of products in the fields of oncology, gynaecology, cardiology, dermatology and podiatry.

These include medical devices in the US as well as in Europe, Canada, Australia, Brazil, China and Japan.  Mairi has also been responsible for designing and implementing quality management systems compliant with medical device regulations and for providing regulatory support for clinical trials throughout Europe.  

Mairi holds a BSc degree in Biology from the University of Paisley.

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