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Learning Level: Advanced
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Javier Varela (he/him/his)

Snr Manager Medtech Services
Pharmalex
Madrid, Madrid, Spain

With more than 12 years of experience in the field of regulatory affairs, I joined PharmaLex Spain in 2018 as a Medical Devices team leader assisting companies in new medical device registration, market access and transition to the Medical Device Regulation 2017/745 (MDR) and 2017/746 (IVDR), especially focused on software as a medical device. Prior to starting at Pharmalex, I obtained experience at Tedec-Meiji as a Regulatory and Quality Assurance Specialist certifying new medical devices, maintaining the medical device portfolio and quality management system according to the requirements of MDD 93/42/EEC and ISO 13485, including regulatory assessment of labelling and promotional materials, and providing support for international registrations of these products at FDA, ANVISA and MENA market and initiating the transition plan to MDR.

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