Regulatory Affairs Manager - Medical Device

TN Italy; Roma; In loco; EUR 45.000 - 80.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Regulatory Affairs Manager to oversee the regulation process for medical devices. This role involves preparing applications, managing clinical investigations, and ensuring compliance with governmental regulations. The ideal candidate will have a Master's Degree in a relevant field, extensive experience in Regulatory Affairs, and proficiency in both English and Italian. Join a dedicated team in a role that offers the opportunity to make a significant impact in the medical device sector, while navigating the complexities of regulatory approval processes.

Competenze

• Master’s Degree in science or related field required; MD is a plus.
• Extensive experience in life sciences and Regulatory Affairs.

Mansioni

• Implement regulatory strategies for Medical Devices via national and international procedures.
• Manage clinical investigations and review related documentation.

Conoscenze

Regulatory Affairs

Communication Skills

Planning Skills

Organizational Skills

Proficiency in English

Proficiency in Italian

Formazione

Master’s Degree in Science

MD

Strumenti

Microsoft Office

Descrizione del lavoro

Regulatory Affairs Manager - Medical Device, Rome

This position is with Meditrial Europe Ltd., located in Rome, Italy. The role requires EU work permit approval and is office-based with potential travel.

Job Details

• Job Reference: d44949a5bc97
• Job Views: 2
• Posted: 06.05.2025
• Expiry Date: 20.06.2025

Job Description

The Regulatory Affairs Manager oversees the regulation process for medical devices and products requiring governmental approval. Responsibilities include preparing applications, handling government interactions, supporting strategic regulatory planning, coordinating inspections, and developing compliance procedures for pre- and post-market activities.

Key responsibilities include:

1. Implementing regulatory strategies for Medical Devices via national and international procedures.
2. Assisting in the creation and updating of Technical Files.
3. Managing clinical investigations and reviewing related documentation.
4. Overseeing post-marketing surveillance activities.
5. Supervising international regulatory and quality assurance activities.

Qualifications

• Master’s Degree in science or a related field; MD is a plus.
• Extensive experience in life sciences and Regulatory Affairs.
• Proficiency in English and Italian; additional languages are a plus.
• Proficient in Microsoft Office.
• Excellent communication, planning, and organizational skills.
• Ability to handle multiple priorities effectively.