Valerie is part of Qserve’s US Regulatory Affairs and Clinical teams providing strategic perspectives from a manufacturer’s point of view with a focus on clinical affairs. Her areas of expertise include regulatory strategy and submissions, quality and risk management implementations/review, and project management.
With over 25 years’ experience, Valerie has a reputation for listening, focusing, and delivering according to her client’s requirements. She was given an opportunity to work in the medical device industry over 6 years ago and has experience working for multi-national corporations and start up organizations. As a regulatory professional with medical writing experience, Valerie has utilized her strategic thinking to develop solutions to assist clients with clinical and regulatory requirements. Valerie has multiple industry experience with successful transitions that include the defense, telecommunications, and transportation industries.
Valerie’s core competences include clinical data collection strategy for the EU, training for Usability, Post Market Surveillance, Risk Analysis, and ClinicalEvaluations in the EU and China, management of Clinical Evaluation remediation projects for both MDD and MDR and strategizing US FDA 510K applications.
Currently, her focus is on designing and implementing Clinical Evaluation strategies for CE certifications for a variety of medical devices (class I, IIa, IIb and class III).
Valerie has a BS degree in Electrical Engineering for Florida Atlantic University and has been a Project Management Professional (PMP) since 2004.