Global Medical Device Regulatory & Quality Associate

Groupe ProductLife; Paris; Hybride; EUR 42 000 - 54 000; Plein temps

Résumé du poste

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.

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.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related 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.

Responsabilités

• 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.

Connaissances

Regulatory mindset

Organizational skills

Communication skills

Detail-oriented

Proactive

Formation

Bachelor’s degree in Life Sciences/Regulatory/related field

Description du poste

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.

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.