Global Medical Device Regulatory & QA Associate

PLG; Courbevoie; Hybrid; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory affairs

Quality management

Cross-functional collaboration

Bilingual: French & English

Ausbildung

Bachelor’s degree in Life Sciences or related field

Jobbeschreibung

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.