To continue to meet the challenges presented in an ever-changing environment and provide the highest quality product to patients, distributors, and partners in the medical device industry.
Knowledgeable in Microsoft Windows, Excel, Word, Access, PowerPoint, Project, ManMan-Reflections, FileMaker Pro, EasyTrack, Agile, PDM, SAP, Acrobat Distiller.
Varian Medical SystemsPalo Alto, CASenior Regulatory Affairs Specialist
Responsible for post-market reporting activities in accordance with FDA and International regulations related to medical device surveillance, product field actions, CAPA, and recall-related activities.
Representing Regulatory Affairs on post-market company project teams.
Submit monthly status reports of corrections and removals to FDA and International agencies.
Point of contact with worldwide regulatory agencies on inquiries regarding MedWatch, Canadian MPR, Vigilance, and Recall activity.
Responsible for recall strategy and customer communications of corrections and removals.
Working with cross-functional departments to deliver project results for CAPA, recall and correction activities.
Participate in multidisciplinary teams focusing on continuous process improvements and company objectives.
Conor MedsystemsMenlo Park, CASenior Regulatory Affairs Associate
Regulatory support of IDE, Health Canada Medical Device License Registration, and on going compliance for product development projects.
Developed and implemented Standard Operating Procedures in accordance with FDA, and European MDD regulations.