Senior QARA Engineer

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

• Ensure the compliance and robustness of the software medical device throughout its lifecycle.


• Integrate quality and regulatory requirements from the design stage and throughout the development lifecycle.


• Maintain and improve the quality management system (QMS) and its operational practices.


• Prepare and maintain regulatory documentation, including technical files and compliance evidence.


• Contribute to post-market surveillance (PMS) activities and interfaces related to clinical studies.


• Structure complaint tracking and lead the associated CAPAs.


• Collaborate with Product, Clinical, Security, and Support teams to make pragmatic decisions.


• Contribute to the continuity of critical activities, including maintaining market access, certifications, and clinical research support.

Requirements

• 5 years of experience in regulatory affairs and/or quality for medical devices under the MDR, ideally in software or healthcare.


• Experience contributing to the maintenance or improvement of a QMS (ISO 13485).


• Experience with technical files and regulatory documentation under the MDR.


• Participation in post-market activities (PMS) and/or complaint management.


• Ability to work on QARA and compliance topics related to medical devices, ideally SaMD.


• Proficiency in a risk-based approach, such as ISO 14971, and the ability to translate it into requirements and evidence.


• Ability to produce clear, structured, audit-ready documentation.


• Ability to collaborate with Product and Tech teams from the design stage.


• Operational proficiency in written and spoken English.


• Rigorous, detail-oriented, self-directed, and solution-oriented.


• Ability to challenge constructively and build consensus without formal authority.


• Strong prioritization skills, pragmatism, reliability, and a cross-functional mindset.


• Knowledge of topics at the intersection of quality and information security, such as ISO 27001, is a plus.


• Experience working in international environments is a plus.


• Experience with clinical studies is a plus.

Core Competencies

Demonstrates expertise in regulatory affairs and quality management for medical devices, with a strong focus on compliance, documentation, and post-market surveillance. Proficient in maintaining quality management systems and collaborating across teams to ensure product integrity and market access.

Highest-signal resume keywords

• Regulatory Affairs Experience


• Quality Management System (ISO 13485)


• Technical Documentation Under MDR


• Post-Market Surveillance (PMS)


• Risk-Based Approach (ISO 14971)

Hard Skills

• Regulatory Documentation


• Quality Management System (QMS)


• Complaint Management


• Post-Market Activities


• Risk Assessment


• Audit-Ready Documentation


• Software as a Medical Device (SaMD)


• ISO 27001 Knowledge


• Clinical Studies Experience


• MDR Compliance

Soft Skills

• Detail-Oriented


• Self-Directed


• Solution-Oriented


• Strong Prioritization Skills


• Cross-Functional Mindset

Industry Keywords

• Medical Devices


• Quality Assurance and Regulatory Affairs (QARA)


• Compliance


• Clinical Research


• International Environments