QAR Manager
Il y a 2 semaines
Guyancourt, Île-de-France
カールストルツ・エンドスコピー・ジャパン（株）
Temps plein
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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
