Medical Device 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

Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward-thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose-driven work.

Job Description

About ProductLife Group

ProductLife Group (PLG) is a global consulting organization supporting pharmaceutical, biotech, and medical device companies throughout the product lifecycle. Our mission is to improve human health by helping clients achieve and maintain regulatory compliance worldwide.

Your Mission

As a Medical Device Associate, you will support regulatory and quality activities for medical devices, ensuring compliance with international regulations and quality standards while contributing to a wide range of client projects.

Key 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.

Profile

• 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.

Why Join PLG

• Work on international and innovative medical device projects.
• Collaborate with regulatory and quality experts worldwide.
• Benefit from continuous learning and professional growth opportunities.
• Join a dynamic company committed to improving patient access to safe healthcare solutions.