Malcolm Applewhite

Qa/ra Manager/consultant at Strait Access Technologies

Malcolm Applewhite, M.Sc, is a seasoned professional in medical device quality assurance and regulatory affairs, currently serving as a consultant at regZAmed Solutions Pty Ltd and Strait Access Technologies, along with a role as Regulatory Affairs Manager at GLYCAR. With extensive experience from previous positions, including Regulatory Affairs Consultant and Risk & Regulatory Compliance Lead at Radic8 Global and QA Manager roles at Cerdak (Pty) Ltd and Dakot Milling Media, Malcolm has demonstrated expertise in establishing quality management systems, maintaining ISO accreditations, and managing regulatory submissions for products. Academically, Malcolm holds a Master of Science in Synthetic Chemistry and a Bachelor of Science in Chemical Biology, complemented by relevant certifications in regulatory practices for medical devices.

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