ClarkeModet España
About Mª José Reyes
A pharmaceutical professional with 29 years’ experience in the pharmaceutical, medical device and in vitro diagnostics sectors at GSK, Grünenthal, J&J, Beckman Coulter, Cardinal Health, Cordis, Stryker and currently as a consultant at ClarkeModet.
Specialised in regulatory affairs, quality management systems, and healthcare regulatory compliance (EMA, FDA, MDR, IVDR, ISO 13485 and 9001). Extensive experience in liaising with European and national competent authorities, audits and inspections, leading international and multidisciplinary teams, and decision-making regarding risk management, complaints, non-conformities, CAPAs, product recalls and field actions.
Specialised in providing independent, evidence-based technical judgements, critically evaluating scientific and regulatory documentation, and preparing safety reports with rigour and precision.
Education
- Bachelor’s degree in Pharmacy, University of Salamanca
- Master’s degree in the Pharmaceutical and Parapharmaceutical Industry, CESIF
- Postgraduate diploma in Health Sciences Statistics, University of Barcelona
- Pharmabusiness EPHOS
- Languages: Spanish, English and German.
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