Regulatory Affairs Manager

Taux horaire: membres seulement

Disponibilité: membres seulement

Disponibilité à voyager: Non spécifié

Statut professionnel: Pigiste

Dernière mise à jour: 25 mars 2026

Expérience de travail totale: 5 année(s)

Connaissances linguistiques: Anglais, Français, Russe,

Sommaire professionel

I’m a Regulatory Affairs and Compliance Manager with 5+ years of experience guiding Software as a Medical Device company towards ISO 13485, ISO 27001, CMDR, and MDSAP compliance. At the intersection of quality, cybersecurity, and regulatory strategy, I specialize in ensuring audit readiness, process efficiency, and optimizing Quality Management Systems. I’ve led 5 successful External Audits (MDSAP, ISO 13485), prepared an FDA 510(k) submission, and developed dozens of Cybersecurity policies and Quality procedures to meet ever-evolving regulatory expectations.

Compétences

DIN EN ISO 134855 MDSAP5 Regulatory affairs management5 FDA 510(k)3 Software quality5

Connaissances linguistiques

Anglais

Langue maternelle

Français

Avancé

Russe

Langue maternelle