Dental Medical Device QMS / MDR Consultant

Pay Rate: €30 per hour

Location: Milan, Italy | Hybrid - 3 days onsite per week

Contract: Full-time

Industry: Dental Medical Devices

Meet Life Sciences is seeking an experienced Quality Management System (QMS) and EU MDR Consultant for a full-time contract opportunity within the dental medical device sector in Milan.

We are looking for a hands-on Quality and Regulatory Affairs professional with strong experience supporting medical device manufacturers in maintaining compliant quality systems and meeting European regulatory requirements.

The idóneo consultant will combine practical ISO 13485 and EU MDR expertise with direct experience in dental medical devices, supporting quality and regulatory activities while collaborating with cross-functional teams.

This opportunity would suit an experienced consultant who is comfortable taking ownership of quality and regulatory deliverables and applying their technical expertise within a regulated manufacturing environment.

Key Responsibilities
- Support the implementation,



maintenance and continuous improvement of Quality Management Systems in accordance with ISO 13485.
- Assess existing quality processes against EU MDR 2017/745 requirements, identifying compliance gaps and supporting corrective actions.
- Prepare, review and maintain technical documentation to support medical device regulatory compliance.
- Support internal and external audits, including preparation for notified body assessments.
- Review and improve quality procedures, SOPs, CAPA processes, deviations and change control activities.
- Support risk management activities in accordance with ISO 14971, ensuring appropriate integration with quality and regulatory processes.
- Collaborate with Quality Assurance, Regulatory Affairs, Engineering and Manufacturing teams to ensure consistent application of regulatory requirements.
- Provide practical guidance on quality and regulatory matters relating to dental medical

📌 Dental Medical Device QMS (Caldera)
🏢 Gartner
📍 Caldera