Stephanie Sheesley, RAC

Stephanie Sheesley, RAC

Stephanie Sheesley, RAC

Associate Director

Stephanie has over 15 years global regulated industry experience in R&D and QA/RA compliance with a majority of her experience specific to medical devices (including dental implants, surgical instruments and surgical lighting). She has extensive experience in quality system implementation in both pharmaceuticals and medical devices in addition to her primary concentration in regulatory submissions and life cycle management of medical devices both domestically and internationally.

Stephanie has successfully authored and received approval /clearance for PMA submissions/Annual Reports (dental implants) and 510(k) PMNs for various types of medical devices, implants, and surgical instruments (laparoscopic/endoscopic, cardiovascular , OB/GYN, and surgical lighting). Throughout her career, Stephanie has strategically led regulatory teams through successful global medical device submissions (e.g., EU, Canada, Japan, and Australia), FDA Inspections, Notified Body/CMDCAS/JPAL Audits and medical device acquisitions.

Work Experience

Prior to joining Parexel, Stephanie held key roles in R&D at the University of Maryland and Wyeth Pharmaceuticals as well as global leadership positions in Quality Assurance/Regulatory Affairs at Adhesives Research (OTC manufacturing partner with Novartis Consumer Health), DENTSPLY International, and Integra LifeSciences, Inc.

Education

Stephanie received her B.S. in Biology with both academic and departmental honors from York College of Pennsylvania. She also maintains her Regulatory Affairs Certification (RAC) in U.S. Regulations from Regulatory Affairs Professionals Society (RAPS).

We are always available for a conversation.

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