Vanessa is a key member of our Regulatory Affairs team focused on medical devices. She is experienced in a range of devices from neurological, dental, orthopaedic and patient specific/custom made type devices in global markets. Vanessa is Medical Device Quality Management Systems Lead Auditor trained. She has expertise that includes project management and new regulation implementation.
Value to clients
Vanessa has a wide breadth of experience covering Classes I-III, & Software devices. She brings strategic planning to all client projects, from design stages through to post-market surveillance and vigilance. Vanessa is strong in Class III implanted devices, technical file and design dossier creation, and maintenance.
- Submission and audit experienced in the EU, USA, Canada and Australia
- Well versed in design controls, risk management activities and labelling
- EU MDR and UDI expert
- Positive mind set, proactive, analytical and great attention to detail
- Pragmatic problem solver.
Vanessa has an Engineering Degree in Biomedical Materials Science and Engineering. Her Regulatory experience began as a Regulatory Affairs Associate at MatOtho Ltd. gaining a firm background in orthopaedics. Since she has worked as a Regulatory Affairs Officer at Renishaw plc, where she expanded her experience to new types of devices and built her expertise in supplier audits and quality management.
Other things about Vanessa
- ISO13485:2016 and MDSAP requirements Lead Auditor
- Audit experience with FDA and Health Canada
- Previous member of trade association MedTech for working groups MDR UDI and Eudamed.