I specialize in guiding medical device and in-vitro diagnostic manufacturers through the full regulatory lifecycle—from clinical and regulatory strategy to post-market performance and surveillance. I have successfully managed multiple MDR and IVDR submissions and Notified Body interactions with BSI, Dekra, TÜV SÜD, and TÜV Rheinland, ensuring compliance and supporting timely market access.

I hold a Master of Science in Applied Clinical and Preclinical Research (Regulatory Affairs) from The Ohio State University and am currently a RAPS RAC Certification candidate. With a strong foundation in regulatory writing, compliance strategy, and client education, I am recognized for delivering practical, solutions-oriented support. My expertise helps manufacturers meet evolving EU and global regulatory requirements while maintaining the highest standards of safety, quality, and performance.