Madeleine is a frequent speaker at SAMED Regulatory Forums, and industry workshops with SAHPRA and other stakeholders, aimed to facilitate efficiencies in the regulation of the medtech industry in South Africa.
Madeleine holds industry positions as SAMED Board Member, long standing member and previous Chair of the SAMED Regulatory Committee, current Chair of the SAHPRA-Industry Medical Device Working Group, member of the Dubai-based MECOMED Regulatory Committee and Africa sub-committee.
She participated in the US-led Medical Device Regulatory Convergence Project with Advamed, and follows the Global Medical Technology Alliance, GHWP and other groupings focussed on international regulatory harmonisation for medical devices.
Madeleine has a professional record of 25 years in leadership positions in the pharmaceutical, medical device and diagnostics industries. Madeleine has expertise in regulatory affairs and quality management for medtech products, including manufacturing, and has led Regulatory Affairs departments for several large multinational companies across a broad spectrum of product types – medical devices, medical imaging equipment, IVD’s, pharmaceuticals, consumer products, etc.
Madeleine has a Master of Science degree in Organic Chemistry from UCT, a Management Diploma from Wits Graduate School of Business and is a qualified ISO13485 Lead Auditor.
