Chargé(e) de mission assurance qualité, affaires réglementaires et études cliniques

Responsibilities

We are representing a confidential medical device organization in the Grand Est region seeking a Quality Assurance, Regulatory Affairs, and Clinical Studies Officer. In this role, you will report to the Director of Quality Assurance and implement technico-regulatory strategy while coordinating clinical studies.

Your core responsibilities include:

• Preparing, monitoring, and controlling regulatory compliance documentation for CE marking (MDR 2017/745 and IVDR 2017/746) and international registrations including FDA and export requirements
• Managing registrations, post-market surveillance, material vigilance, and incident reporting
• Verifying regulatory compliance of promotional materials
• Coordinating the implementation and monitoring of clinical studies in collaboration with R&D teams
• Participating in ethical compliance, data analysis, and clinical report writing
• Analyzing and evaluating product-related risks, participating in opportunity analyses and KPI monitoring
• Contributing to the implementation and maintenance of Quality Management Systems (ISO 13485, ISO 9001)
• Conducting or participating in internal audits
• Managing corrective and preventive action plans and executing corrective or preventive actions
• Ensuring regulatory and normative surveillance (JOUE, ANSM, FDA, etc.) and representing the organization with competent authorities and notified bodies

What We're Looking For

Our talent team is seeking candidates with:

• Advanced degree (Bac+5) in Regulatory Affairs, Life Sciences, Pharmacy, or related field, or significant experience in Quality Assurance/Regulatory Affairs
• Strong knowledge of MDR 2017/745 and IVDR 2017/746 regulations
• Expertise in ISO 13485 and ISO 9001 standards
• Understanding of medical data protection and clinical study management
• Professional-level English proficiency
• Rigor and autonomy in work approach
• Dynamic personality with enthusiasm and strong interpersonal skills
• Team-oriented mindset with ability to communicate effectively with diverse stakeholders including R&D, technical services, and quality departments

How We Work With You

Candidates apply directly through Get A Job.ai. Our recruiting team will conduct an initial screening and interview qualified candidates. We then submit your profile to our client for consideration. Please do not contact the client directly, as all communication flows through our recruitment process to ensure the best experience for both parties.

Pay

Compensation details will be discussed during the screening process with our recruitment team.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive recruitment practices. We welcome applications from all qualified candidates regardless of background, and all positions are open to individuals with disabilities.