Medical Devices Associate

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.