Alternant(e)- Chargé(e) Assurance Qualité et Affaires Réglementaires
Core
Support the implementation of a Quality Management System (QMS) compliant with ISO 13485 and contribute to regulatory compliance for medical devices.
Role type
Quality Assurance and Regulatory Affairs Intern
Builds
Quality Management System (QMS) and regulatory compliance documentation
Domain
Medical Devices / Healthcare
Required skills
ISO 13485 knowledge, European Medical Device Regulation (MDR 2017/745) knowledge, French regulatory knowledge, English proficiency, scientific/medical/engineering background
Preferred skills
Knowledge of the Professional Practices Quality Charter
Technologies
ISO 13485, MDR 2017/745
Responsibilities
Participate in QMS implementation, contribute to training on QMS requirements, manage documentation (procedures, instructions, records), intervene on key processes (CAPA, document control, medical device vigilance), track performance indicators, participate in regulatory compliance actions, conduct regulatory monitoring, participate in regulatory controls related to the Anti-Gift Law, contribute to transparency data publication
Seniority
Intern