QAR Manager & subsitute materiovigilance (m/f/d)

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