Desiree MacChia

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.

Experience

1. Medical Writer (Regulatory)

   Global Regulatory Writing & Consulting (GLOBAL)

   Jun 2024 — Present

   Technical document mastery of EU MDR regulatory documents including Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Summary of Safety and Clinical Performance (SSCP), Periodic Safety Update Reports (PSUR), Post-market Clinical Follow-up (PMCF) Plans and Reports, and Post-market Surveillance (PMS) Plans Expertise in the EU MDR regulatory landscape for Class IIa and Class devices, specifically for peripheral intervention and cardiovascular devices Authored comprehensive SOA assessments and responsible for clinical literature appraisal and data extraction Acted as primary liaison for multiple business units including Med Safety, Clinical Risk, Reg Affairs, and R&D to streamline the document approval process

Education

• Aliso Niguel High School

  High School

  2008 — 2012

• University of California, Berkeley

  Bachelor’s Degree, Molecular and Cell Biology - Neurobiology

  2012 — 2016

• UC Irvine

  Doctor of Philosophy - PhD, Biomedical Sciences

Skills

• Neuroanatomy
• Genotyping
• Behavioral Neuroscience
• Mouse Models
• Genomics
• Microscopy
• Intravenous Injections
• Rna Isolation
• Pcr
• Molecular Biology
• Fluorescence Microscopy
• Rodents
• Human Anatomy
• Slide Preparation
• Research
• Hamster Handling
• Mouse Handling
• Genetics
• Cryostat
• Systems Neuroscience
• Neuroendocrinology
• Dna Extraction
• Immunohistochemistry
• Cdna Synthesis
• Cell Biology
• Biotechnology
• Gel Electrophoresis
• Cell Culture
• Polarized Light Microscopy
• Neurobiology
• Science
• Biochemistry
• Neuroscience