Quality & Regulatory Apprentice: ISO 13485, MDR & Audits

カールストルツ・エンドスコピー・ジャパン（株）; Guyancourt; Sur place; EUR 12 000 - 17 000; Plein temps

Avantages offerts par ce poste

Health insurance

Vacation days (25 days /year)

Additional days (between 10 or 13 days

Lunch vouchers

Opportunity to work in aninternational

A supportive team and modern working环境

Résumé du poste

KARL STORZ France is seeking an Apprentice in the Quality and Regulatory Department to support regulatory intelligence, maintain the QMS per ISO 13485, draft procedures, participate in audits, monitor KPIs, and assist with complaints and vigilance.

The candidate should be pursuing a Bachelor's or Master's in Quality Management, Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field, with interest in medical device regulations, strong English/French, and MS Office

Qualifications

• Currently pursuing a Bachelor's or Master's degree in Quality Management, Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field.
• Strong interest in medical device regulations, quality systems, and compliance requirements.
• Basic knowledge of ISO 13485 and EU MDR is advantageous.
• Good analytical and problem-solving skills with attention to detail.

Responsabilités

• Contribute to regulatory intelligence and monitoring (ISO standards, EU regulations, FDA requirements).
• Support maintenance and improvement of the QMS per ISO 13485.
• Assist drafting, review, and updating quality procedures and documentation.
• Participate in internal audits and support external audits/inspections.
• Monitor KPIs and help with continuous improvement initiatives.
• Assist in handling customer complaints, vigilance, and recalls.

Connaissances

Regulatory affairs interest

Regulatory compliance

Analytical skills

French and English communication

MS Office proficiency

Cross-functional teamwork

Formation

Bachelor's or Master's in Quality Management or Regulatory Affairs

Biomedical Engineering or Life Sciences

Outils

MS Office (Excel, Word, PowerPoint)

SharePoint

Power BI

Description du poste

KARL STORZ France is seeking an Apprentice in the Quality and Regulatory Department to support regulatory intelligence, maintain the QMS per ISO 13485, draft procedures, participate in audits, monitor KPIs, and assist with complaints and vigilance.

The candidate should be pursuing a Bachelor's or Master's in Quality Management, Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field, with interest in medical device regulations, strong English/French, and MS Office