Medical Device Associate

PLG; Courbevoie; Hybrid; EUR 45,000 - 60,000; Full time

Job summary

ProductLife Group is seeking a Medical Device Associate to support regulatory and quality activities across international markets. You will help ensure compliance with MDR/IVDR, ISO 13485, and related quality systems, while collaborating with cross-functional teams.

The role requires a Life Sciences degree and experience in regulatory affairs or QA, with fluency in French and English and the ability to work in an international environment. Hybrid work from Courbevoie.

Qualifications

• Bachelor’s degree or equivalent in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, or related field.
• Experience in Medical Device Regulatory Affairs and/or Quality Assurance.
• Solid knowledge of MDR, IVDR, ISO 13485, Technical Documentation, CAPA, and quality systems.
• Excellent organizational and communication skills.
• Fluent in French and English; able to work in an international environment.

Responsibilities

• Support regulatory affairs activities across international markets for medical devices.
• Prepare, maintain, and review quality documentation including SOPs, work instructions, and templates.
• Contribute to Technical Documentation, STEDs, and Declarations of Conformity.
• Review Labelling and advertising documents for compliance.
• Support CAPA management, non-conformity investigations, and quality improvement actions.
• Participate in internal and external audits, including ISO 13485-related activities.
• Assist regulatory registration and approval activities, including EU and FDA projects.
• Monitor regulatory developments and assess impact on projects.

Skills

Regulatory affairs

Quality management

Cross-functional collaboration

Bilingual: French & English

Education

Bachelor’s degree in Life Sciences or related field

Job description

## Medical Device AssociateApply: Hybrid: Courbevoie Office: Full time: Posted 11 Days Ago: End Date: December 31, 2026 (30+ days left to apply): JR000049Make 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.**Ready to make an impact? Join PLG and help shape the future of medical device compliance.**Ready to take the next step? Apply today and join a global, innovative team that’s shaping the future of life sciences and empowering people to make a real impact in healthcare.