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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory Affairs Manager at LightDeck Diagnostics
Lafayette, CO (USA)
RAC holder since 2020
As an intern in engineering school, I worked in the project management office of a medical device company assisting with many different functions. I got to work with regulatory affairs in building a database of regulatory approvals. I was fascinated by how disparate the regulatory requirements were for each country. I left the project management office but carried those skills into my first full-time role in regulatory affairs. From that time almost a decade ago, I am still fascinated at the evolution of regulatory science in government bodies around the world to ensure the safe and effective use of medical devices.
I work from home during the pandemic, and my focus is entirely on COVID-19 Emergency Use Authorization (EUA) preparation for the In Vitro Diagnostic tests made by my organization. I work with project teams in testing, validating the tests, and gathering regulatory inputs from the FDA in this fast-paced era of COVID-19.
RAPS has been a critical part of every organization I have worked for—from the very first one I joined. Regulatory affairs as a profession has a very organizationally-focused mindset and that's what inspired me to join the leading edge of our industrial group. They do a fantastic job supporting the profession, from news sharing to skills building.
I received the RAC Devices certification in the Fall of 2020. Certification gave me an enormous boost in performance at my job. Prior to entering my new organization in the IVD field, I had not studied that type of device. I learned a large amount from the RAPS book and study materials about IVDs that I use in my job every day. As the regulatory leader at my organization, I would encourage anyone who is passionate about regulatory affairs to pursue the RAC.