Regulatory Affairs and Quality Officer

Normandy Hadrontherapy; Caen; Hybride; EUR 52 000 - 78 000; Plein temps

Résumé du poste

Normandy Hadrontherapy is seeking a Regulatory Affairs and Quality Officer to reinforce the Regulatory Affairs and Quality Department and help achieve its objectives. You will draft and update the Quality Management System, support QMS activities, monitor regulatory standards, prepare CE marking documentation, promote quality across the company, and train staff in QARA.

Fluent English and IT proficiency are required.

Qualifications

• Bachelor’s or Master’s degree (3–5 years of higher education) and/or at least 4 years of experience in a Quality Assurance / Regulatory Affairs department.
• Excellent writing and interpersonal skills.
• Good knowledge of the regulatory and standards environment for medical devices (ISO 13485, MDR 2017/745).
• Professional proficiency in English.
• Proficiency in IT tools.
• Strong attention to detail, autonomy, organizational skills, curiosity, and proactivity, with the ability to work cross-functionally on multiple topics simultaneously

Responsabilités

• Contribute to the drafting and updating of the Quality Management System (QMS).
• Support the implementation of QMS-related activities, including change management, non-conformity management, and document control.
• Contribute to regulatory and standards monitoring.
• Participate in the preparation of the CE marking technical documentation.
• Promote and communicate the quality approach throughout the company.
• Coordinate and deliver Quality Assurance and Regulatory Affairs (QARA) training sessions for employees.
• Report on activities to their manager to ensure the successful completion of QARA activities.
• Alert the Department Manager in the event of any operational issues.

Connaissances

Excellent writing and interpersonal

Attention to detail

Autonomy

Organizational skills

Cross-functional collaboration

Formation

Bachelor’s or Master’s degree in a relevant field

Outils

IT tools

Description du poste

The Regulatory Affairs and Quality Officer will strengthen the Regulatory Affairs and Quality Department and contribute to achieving its objectives.

1 Description of Activities

Contribute to the drafting and updating of the Quality Management System (QMS).

Support the implementation of QMS-related activities, including change management, non-conformity management, and document control.

Contribute to regulatory and standards monitoring.

Participate in the preparation of the CE marking technical documentation.

Promote and communicate the quality approach throughout the company.

Coordinate and deliver Quality Assurance and Regulatory Affairs (QARA) training sessions for employees.

2 Associated Responsibilities and Level of Autonomy

Ensure compliance with quality procedures and the proper use of internal documentation.

Report on activities to their manager to ensure the successful completion of QARA activities.

Alert the Department Manager in the event of any operational issues.

3 Internal / External Working Relationships

Reports to NHa’s Regulatory Affairs and Quality Manager.

Works with NHa’s internal departments and external service providers.

4 Specific Professional Knowledge

Bachelor’s or Master’s degree (3–5 years of higher education) and/or at least 4 years of experience in a Quality Assurance / Regulatory Affairs department.

Excellent writing and interpersonal skills.

Good knowledge of the regulatory and standards environment for medical devices (ISO 13485, MDR 2017/745).

Professional proficiency in English.

Proficiency in IT tools.

Strong attention to detail, autonomy, organizational skills, curiosity, and proactivity, with the ability to work cross-functionally on multiple topics simultaneously