Senior QARA Engineer — SaMD Compliance & QMS Lead

Jobtailor; Paris; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Jobtailor in Paris seeks an experienced Regulatory Affairs and Quality professional to ensure software medical device compliance throughout its lifecycle. You will integrate MDR requirements from design to development, maintain QMS practices, and prepare regulatory documentation.

You will contribute to PMS activities, manage complaints and CAPAs, and collaborate with Product, Clinical, Security, and Support teams to support market access and certifications.

Qualifications

• Experience in regulatory affairs or quality for medical devices under MDR.
• Maintenance or improvement of a QMS (ISO 13485).
• Experience with MDR technical files and regulatory documentation.
• Participation in PMS and/or complaint management.
• QARA/compliance topics for medical devices (SaMD).
• Ability to apply ISO 14971 risk management to requirements and evidence.
• Produce clear, structured audit-ready documentation.
• Collaborate with Product and Tech teams from design stage.
• Operational proficiency in written and spoken English.

Responsabilités

• Ensure compliance and robustness of the software medical device throughout its lifecycle.
• Integrate quality and regulatory requirements from design stage through development lifecycle.
• Maintain and improve the QMS and its practices.
• Prepare and maintain regulatory documentation, including technical files and compliance evidence.
• Contribute to PMS activities and clinical study interfaces.
• Structure complaint tracking and lead CAPA processes.
• Collaborate with Product, Clinical, Security, and Support teams for pragmatic decisions.
• Support continuity of market access, certifications, and clinical research activities.

Connaissances

Regulatory Affairs Experience

Quality Management System (ISO 13485)

MDR Knowledge

Technical Documentation

Post-Market Surveillance (PMS)

Risk Management ISO 14971

Software as a Medical Device (SaMD)

Audit-Ready Documentation

Cross-Functional Collaboration

English Proficiency

Description du poste

Jobtailor in Paris seeks an experienced Regulatory Affairs and Quality professional to ensure software medical device compliance throughout its lifecycle. You will integrate MDR requirements from design to development, maintain QMS practices, and prepare regulatory documentation.

You will contribute to PMS activities, manage complaints and CAPAs, and collaborate with Product, Clinical, Security, and Support teams to support market access and certifications.