About this role
KARL STORZ France is looking for a Quality & Regulatory Manager : Implement and maintain regulatory strategies for medical devices, ensuring compliance with national and international requirements. Monitor and interpret regulatory developments, assessing their impact on business activities and products. Manage vigilance, complaint handling, and post-market surveillance activities in collaboration with field teams and headquarters.
Support Field Safety Corrective Actions (FSCA), Field Safety Notices (FSN), and product recalls when required. Maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 13485 requirements. Lead quality improvement initiatives, including CAPA management, quality planning, document control, and supplier qualification activities.
Prepare for and participate in internal and external audits, ensuring ongoing compliance and certification readiness. Provide regulatory guidance, review promotional and training materials, and deliver training and awareness programs to internal stakeholders. Your profile is : Master’s degree (Bac+5) in Regulatory Affairs, Quality, Biomedical Engineering, Health Law, or a related scientific field.
Minimum 3 years of experience in Medical Device Regulatory Affairs and/or Quality Management Systems. Fluent in English Strong proficiency in Microsoft Office applications (Word, Excel, PowerPoint). Solid knowledge of Medical Device regulations and standards, including MDR (EU) 2017/745, MDD 93/42/EEC, and ISO 13485.
Strong scientific background with the ability to interpret regulatory requirements and assess compliance risks. Experience in Quality Management Systems, including quality documentation, process validation, and continuous improvement activities. Strong communication, interpersonal, and training skills, combined with rigor, organization, diplomacy, and a proactive mindset.
Your Benefits Health insurance Vacation days (25 days /year) Additional days (between 10 or 13 days /year) Lunch vouchers Opportunity to work in an international and well-known company A supportive team and modern working-environment