Freelancer profile translated to English.
Back to original languageAbout Chanerle Sonia
Passionate about medical devices and the pharmaceutical industry, I have developed a solid understanding of the sector's quality and regulatory challenges through my experiences.
Organized, rigorous, and curious, I wish to join a team as a Quality and Regulatory Affairs Officer to actively contribute to the compliance of health products and patient safety.
French
Native or bilingual
English
Fluent
German
Conversational
Can work on-site
Paris (up to 50km)
Experience
- Erce médical (CDD)Quality and Regulatory Affairs OfficerOctober 2025 - December 2025 (2 months)Oyonnax, France
- Document management: Updating technical files in the context of the transition to MDR (Class Im medical devices), control of records, drafting and updating procedures and work instructions
- Regulatory and normative watch
- Ercemédical(01100)Quality and Regulatory Affairs TraineeOctober 2024 - October 2025 (1 year)Oyonnax, France
- Post-market surveillance: Drafting of the post-market surveillance report
- Production monitoring: Batch release, drafting of certificates of conformity and analysis, recording and analysis of non-conformities, CAPA monitoring, quality control and metrology, monitoring of rejects and particle counting
- Audits: Participation in internal and external audits
- Regulatory and normative watch: Monitoring of regulatory and normative developments (MDR, applicable standards), impact analysis and contribution to compliance
- BetangEngineeringSarl(CDD)Maintenance Project AssistantFebruary 2022 - April 2023 (1 year and 2 months)Douala, Cameroon
- Planning and scheduling of maintenance work
- Monitoring of quality performance indicators Selection of service providers and control of works
- Analysis of reports and evaluation of action effectiveness Updating of technical documentation
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Education
- Master 2 in Technical and Regulatory Affairs for Medical Devicespolytechnique2024Master 2 en Affaires Techniques et Réglementaires des Dispositifs Médicaux
- Master 1 in Biomechanics and BioengineeringUniversité de Technologie de Compiègne2024Master 1 en Biomécanique et Bioingénierie
Skill set
Categories
- Other