Quality & Regulatory Affairs Lead – Medical Devices

Normandy Hadrontherapy; Caen; Hybrid; EUR 52,000 - 78,000; Full time

Job summary

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

Responsibilities

• 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.

Skills

Excellent writing and interpersonal

Attention to detail

Autonomy

Organizational skills

Cross-functional collaboration

Education

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

Tools

IT tools

Job description

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.