Global Medical Device Regulatory & Quality Associate

ProductLife France; Courbevoie; Hybrid; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid & flexible working

Continuous learning

International environment

Career growth

Job summary

ProductLife Group is seeking a Medical Device Associate to support regulatory and quality activities for medical devices across international markets. You will work on MDR/IVDR compliance, Technical Documentation, CAPA, and audit support in a dynamic global team.

The role requires a Life Sciences degree, experience in regulatory affairs, and fluency in French and English. Hybrid & flexible working is offered with continuous learning opportunities and international exposure.

Qualifications

• Experience in Medical Device Regulatory Affairs and/or Quality Assurance.
• Knowledge of MDR, IVDR, ISO 13485 and Technical Documentation.
• Excellent organizational and communication skills.
• Fluent in French and English.

Responsibilities

• Support regulatory affairs activities for medical devices across international markets.
• Prepare, maintain, and review quality documentation including SOPs, working instructions, and templates.
• Contribute to the preparation and maintenance of Technical Documentation, STEDs, and Declarations of Conformity.
• Review Labelling and advertising documents.
• Support CAPA management, non-conformity investigations, and quality improvement activities.
• Participate in internal and external audits, including ISO 13485-related activities.
• Support regulatory registration and approval activities, including EU and FDA-related projects.
• Monitor regulatory developments and assess their impact on projects and processes.
• Contribute to KPI tracking and reporting through PLG systems and tools.
• Collaborate with cross-functional and international teams to deliver high-quality client services.

Skills

Regulatory Affairs

Quality Assurance

MDR/IVDR

ISO 13485

Technical Documentation

Education

Bachelor's degree in Life Sciences

Regulatory Affairs Certification

Job description

ProductLife Group is seeking a Medical Device Associate to support regulatory and quality activities for medical devices across international markets. You will work on MDR/IVDR compliance, Technical Documentation, CAPA, and audit support in a dynamic global team.

The role requires a Life Sciences degree, experience in regulatory affairs, and fluency in French and English. Hybrid & flexible working is offered with continuous learning opportunities and international exposure.