Professional Summary
Manuel Mateos has over 15 years of experience in the medical device and pharmaceutical industries, where he has successfully led global regulatory strategies and implemented quality systems to support international market access.
He currently serves as CEO of CMC Consulting Group S.L. and Regulatory Affairs Director at CMC Medical Devices & Drugs S.L., contributing to strategic business decisions and overseeing regulatory operations. He has led numerous successful CE mark approvals for Class I, IIa, IIb, III, and in vitro diagnostic (IVD) products.
Academic Background
Manuel holds a degree in Pharmacy and has pursued advanced training in international regulatory affairs, quality management systems, and business leadership. He has participated in several professional development programs and specialized seminars on European, North American, and Latin American regulations.
Key Experience
His expertise includes authoring, reviewing, and validating technical and regulatory documentation, as well as designing global registration roadmaps.
He maintains direct communication with Notified Bodies and Competent Authorities and has in-depth knowledge of regulatory frameworks including MDR 2017/745, IVDR 2017/746, 93/42/EEC, 98/79/EEC, FDA, Health Canada, and Latin American requirements.
Currently, he leads a multidisciplinary team and manages regulatory and commercial relationships with clients and partners worldwide.
Certifications and Memberships
Manuel is highly skilled in implementing and auditing quality management systems according to ISO 13485, ISO 11135, ISO 9001, and MDSAP. He frequently collaborates with international manufacturers and consulting firms as an external regulatory expert and has participated as a speaker in various industry events.
