Senior Director
MEDIcept
Richelle brings more than 35 years of medical device experience to MEDIcept. Her main areas of expertise are regulatory submissions and the product realization process. Richelle has successfully obtained worldwide regulatory clearance for numerous products and managed various large and small complex, cross- functional projects throughout her career.
Her medical device industry experience includes working with both electro-mechanical and disposable medical devices within the clinical disciplines of cardiovascular, ophthamology, urology, nerve stimulation and respiratory.
Before joining MEDIcept, Richelle served as Vice President of Quality, Regulatory and R&D with a respiratory company on the front lines of the COVID pandemic, where she successfully led these functional areas and managed the project to develop and launch the company’s next generation technology.
With an engineering background (mechanical and biomedical), Richelle is proficient at leading teams through the product development process and writing regualtory submissions leading to successful product clearances and approvals.
As a certified Regulatory Affairs Professional and experienced certified auditor, Richelle has an in-depth knowledge of wordwide regulatory and ISO product requirements pertaining to product submissions, product development, risk management, and post-market activities.
Richelle holds a Bachelor’s of Science in Mechanical Engineering from Union College, a Master’s of Science in Biomedical Engineering from Boston University, a Master’s in Business Administration from Northeastern University, a Graduate Certificate in Regulatory Affairs from Northeastern University and Regulatory Affairs Certification from the Regulatory Affairs Professional Society (RAPS).
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