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Erica Nicolae

Erica Nicolae

Senior Director, Quality and Regulatory Affairs

Erica is a seasoned quality leader in the medical device space, bringing more than 20 years of experience in progressively senior quality roles across global organizations including Abbott Laboratories, ArthroCare, Medtronic, Apollo Endosurgery, and Smith & Nephew.  Erica is passionate about people, with a significant focus and track record in delivering successful audit outcomes and achieving upgraded compliance certificates (e.g., MDSAP, EU MDR, ISO 13485:2016, etc).  Most recently, Erica was Director of Quality in the Sports Medicine franchise for Smith & Nephew, where she had responsibility for leading and maintaining the compliance of two quality management systems with two notified bodies, and led the cross-functional collaboration efforts necessary to achieve MDSAP and EU MDR certification. 

Erica holds a BA degree in International Comparative Policy Studies from Reed College, and a Master’s Degree in International Relations and European Studies from the Central European University.