QA Tester ensuring quality software for mobile applications at JustDice GmbH. Working in a hybrid environment, collaborating closely with development and product teams for continuous improvement.
About the role
- Join a leading firm as an experienced QARA Consultant focusing on diverse medical device projects. Engage with varied clients while managing regulatory reporting and compliance in a collaborative team.
Responsibilities
- La rédaction et la mise à jour de dossiers techniques sous MDR (2017/745)
- La définition et le pilotage de stratégies réglementaires
- La gestion des risques selon l’ISO 14971
- La mise en conformité et l’amélioration de SMQ ISO 13485
- Les interactions avec les Organismes Notifiés
- L’accompagnement des clients en phase de développement ou de transition réglementaire
- Après une phase d’intégration, vous gérez 2 à 3 projets en parallèle en toute autonomie.
Requirements
- Bac+5 scientifique (ingénieur, biomédical…)
- Minimum 5 ans d’expérience en QARA dispositifs médicaux
- Maîtrise opérationnelle du MDR
- Expérience d’interaction avec un Organisme Notifié
- Anglais courant (écrit indispensable C1)
- Seront appréciés : Expérience FDA / 510(k)
- Dispositifs classe III
- Logiciels médicaux (IEC 62304)
- Connaissances en cybersécurité / IA
Benefits
- Environnement coopératif avec possibilité d’intégration au capital après un an
- Forte autonomie et diversité des projets
- Travail en équipe experte et collaborative
- Peu de déplacements (1 à 2 par mois)
- 2 jours de télétravail par semaine
Job title
Job type
Experience level
Salary
Degree requirement
No Education Requirement
Location requirements
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