MDR Regulatory Affairs Specialist – Medical Devices

Alchimia srl; Ponte San Nicolò; Ibrido; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading medical device manufacturer in Italy is seeking a Regulatory Affairs Specialist to manage technical documentation and compliance with EU regulations. The ideal candidate has 2–3 years of experience in the medical device sector and strong knowledge of MDR. This position offers a hybrid work model and opportunities for professional growth, contributing significantly to key regulatory projects.

Servizi

Hybrid working model

Meal vouchers

Welfare benefits

Opportunities for professional growth

Competenze

• Minimum 2–3 years of experience in Regulatory Affairs within the medical device sector.
• Previous experience with Notified Bodies and technical file submissions.
• Solid knowledge of regulatory documentation practices.

Mansioni

• Prepare and maintain the Technical Documentation and Design Dossiers in compliance with EU MDR.
• Support certification processes and manage non-conformities.
• Collaborate with teams for regulatory documentation improvement.

Conoscenze

Knowledge of MDR 2017 / 745

Strong English skills (written and verbal)

Problem-solving skills

Attention to detail

Knowledge of ISO 13485

Knowledge of ISO 14971

Knowledge of ISO 10993

Formazione

Degree in scientific discipline

Descrizione del lavoro

A leading medical device manufacturer in Italy is seeking a Regulatory Affairs Specialist to manage technical documentation and compliance with EU regulations. The ideal candidate has 2–3 years of experience in the medical device sector and strong knowledge of MDR. This position offers a hybrid work model and opportunities for professional growth, contributing significantly to key regulatory projects.