VP International Regulatory Affairs
Susan is qualified and very experienced in project management conducting literature studies, technical writing and editing of medical-scientific-engineering documents, as well as Gap Analyses of all international Quality and Regulatory aspects related to many types of Medical Devices.
Before joining Qserve, Susan was QA/RA Manager for a medical device company manufacturing Class III medical implants.
Expert in due diligence and strategic planning. Susan is an advanced certified biological safety (toxicological) expert for Medical Devices. She has a broad scientific background holding advanced degrees in both Biology, Geology, and Information Science and Technology.
Development and performance of various Training Programmes, in company and in-house. Regulatory Submissions, Sterilization Validation, Biocompatibility, Stability and Shelf-Life, Technical Writing, Design and Development, User Needs/Clinical Evaluation, Usability and Risk Management Training.
Learn more about our services within Regulatory Affairs