Guru providing regulatory affairs services to the medical device and pharmaceutical industries.
Guru providing regulatory affairs services to the medical device / medtech, biotech, and pharmaceutical industries. Qualification supported by over 9 years of experience in the field, including 6 years working at the US Food and Drug Administration (FDA - ORA and CDRH), and a solid educational background with a Master’s of Science (MS) in Biomedical Engineering, MS in Pharmacy, Regulatory Affairs Certificate, and a Regulatory Affairs Certification (RAC Global). Driven by a keen interest in the field, developed expertise in and acquired substantial knowledge on the US, EU, and global regulations of medical devices, pharmaceutical products (drugs, biologics), and combination products. I can also leverage my FDA background for cosmetics, dietary supplements, and foods as well.