Pay Rate: €30 per hourLocation: Milan, Italy | Hybrid – 3 days onsite per weekContract: Full-timeIndustry: Dental Medical DevicesLanguage: Fluent Italian requiredMeet 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 ideal 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 ResponsibilitiesSupport 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 devices.Support the development and implementation of corrective actions to address identified quality and regulatory compliance gaps.Candidate Requirements:Demonstrable experience in Quality Assurance, Regulatory Affairs or QMS consultancy within the medical device industry.Strong working knowledge of ISO 13485 and EU MDR 2017/745.Previous experience working directly with dental medical devices or dental device manufacturers.Hands-on experience implementing, maintaining or improving medical device Quality Management Systems.Experience preparing or reviewing technical documentation and supporting regulatory compliance activities.Strong understanding of quality processes, including CAPA, change control, deviations and audit preparation.Ability to work independently, manage priorities and deliver practical solutions within a regulated environment.Fluent ItalianAvailability to work full-time, including three days per week onsite in Milan.If you are an Italian-speaking Quality or Regulatory Affairs professional with dental medical device experience and are interested in a full-time contract opportunity in Milan, we would welcome a confidential conversation.Please note: Applicants must have relevant medical device QMS and/or EU MDR experience, professional Italian language proficiency and the ability to work onsite in Milan three days per week.Applications that do not meet these essential requirements will not be considered.

📌 Dental Medical Device Qms / Mdr Consultant (Roma)
🏢 Meet Life Sciences
📍 Roma