Professional Summary

Michelle’s career has involved leading life science consulting firms and international, technical teams across the US, Asia and Europe. She is well versed in compliance regulations for the pharmaceutical, cannabis and medical device industries. She has led ISO certifications, manufacturing risk assessments, manufacturing facility audits, FDA regulatory clearances, and Health Canada License registrations.

In 2020, she acquired Compliance Team to blend FDA regulatory affairs services from her first company, Guideline Medical, with specialized, FDA Engineering, Compliance services of Compliance Team. Here, she leads the company’s strategic direction and vision. She ensures the team is executing on corporate vision, expanding cannabis service offerings, and maintaining a dynamic work culture.

Michelle has successfully completed FDA regulatory certificate programs and is an active member of MedTech and Women in Construction of upstate New York.