Paméla is employed as a Senior Consultant Clinical Development at Key2Compliance® and has a background as a registered nurse and more than 15 years’ experience from medical device industry.
Paméla’s role is primarily to support with overall clinical development of medical devices, primarily within clinical investigation field. This can include Site qualification, Site Initiation, Interim Monitoring and Close Out Visits to ensure ISO 14155, regulatory and Clinical Investigation Plan (CIP) compliance as well as development of different supporting documents and submission support to ethical review board and or competent authorities.
Paméla has several years of experience from working in Clinical Research Organizations as CRA/Monitor, Lead Monitor and start Up Specialist. In addition, several years’ experience from a medical device entire process from prototype to CE marked device. Paméla also support in Clinical Evaluation Plan and reporting as well as with PMCF.