Desiree MacChia

Background

About Desiree MacChia

I am a PhD-trained Regulatory Medical Writer with nearly 2 years of medical device writing experience authoring biomedical documentation within a full-service CRO. Specializing in the EU MDR landscape, I have successfully managed and authored multiple MDR-compliant Clinical Evaluation Reports (CERs) for Class IIa and Class medical devices, specifically within the cardiovascular and peripheral intervention spaces. My background combines technical writing expertise with a proven ability to lead collaboration between cross-functional stakeholders. I excel at liaising with business units across Med Safety, Clinical Risk, Regulatory Affairs, and R&D to streamline the document approval processes and ensure timely, high-quality deliverables. My specialized skill set includes clinical literature extraction, complaint handling, and regulatory strategy development, all with the ultimate goal of ensuring patient safety.