Global Medical Device Regulatory & Quality Associate

ProductLife Group; Courbevoie; On-site; EUR 50,000 - 70,000; Full time

Job summary

ProductLife Group, a global regulatory and quality consulting leader, seeks a Medical Device Associate to support regulatory and quality activities for medical devices international markets. You will contribute to regulatory registrations, CAPA processes, and documentation updates, collaborating with cross-functional teams worldwide.

Ideal candidates hold a Life Sciences degree and have experience with MDR/IVDR, ISO 13485, and technical documentation, plus fluency in French and English.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related scientific field.
• Experience in Medical Device Regulatory Affairs and/or Quality Assurance.
• Knowledge of MDR, IVDR, ISO 13485, Technical Documentation, CAPA, and quality systems.
• Excellent organizational and communication skills.
• Fluent in French and English.
• Proactive, detail-oriented, and able to work in an international environment.

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

Technical documentation

Cross-functional collaboration

Project communication

French language

English language

Education

Bachelor's degree in Life Sciences

Job description

ProductLife Group, a global regulatory and quality consulting leader, seeks a Medical Device Associate to support regulatory and quality activities for medical devices international markets. You will contribute to regulatory registrations, CAPA processes, and documentation updates, collaborating with cross-functional teams worldwide.

Ideal candidates hold a Life Sciences degree and have experience with MDR/IVDR, ISO 13485, and technical documentation, plus fluency in French and English.