pstrongPay Rate: €30 per hour /strong /ppstrongLocation: /strong Milan, Italy | Hybrid – 3 days onsite per week /ppstrongContract: /strong Full-time /ppstrongIndustry: /strong Dental Medical Devices /ppstrongLanguage: /strong Fluent Italian required /ppbr / /ppMeet 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. /ppbr / /ppWe 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. /ppbr / /ppThe 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. /ppbr / /ppThis 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. /ppbr / /ppstrongKey Responsibilities /strong /pulliSupport the implementation, maintenance and continuous improvement of Quality Management Systems in accordance with ISO 13485. /liliAssess existing quality processes against EU MDR 2017/745 requirements, identifying compliance gaps and supporting corrective actions. /liliPrepare, review and maintain technical documentation to support medical device regulatory compliance. /liliSupport internal and external audits, including preparation for notified body assessments. /liliReview and improve quality procedures, SOPs, CAPA processes, deviations and change control activities. /liliSupport risk management activities in accordance with ISO 14971,



ensuring appropriate integration with quality and regulatory processes. /liliCollaborate with Quality Assurance, Regulatory Affairs, Engineering and Manufacturing teams to ensure consistent application of regulatory requirements. /liliProvide practical guidance on quality and regulatory matters relating to dental medical devices. /liliSupport the development and implementation of corrective actions to address identified quality and regulatory compliance gaps. /li /ulpbr / /ppstrongCandidate Requirements: /strong /ppbr / /pulliDemonstrable experience in Quality Assurance, Regulatory Affairs or QMS consultancy within the medical device industry. /liliStrong working knowledge of ISO 13485 and EU MDR 2017/745. /liliPrevious experience working directly with dental medical devices or dental device manufacturers. /liliHands-on experience implementing, maintaining or improving medical device Quality Management Systems. /liliExperience preparing or reviewing technical documentation and supporting regulatory compliance activities. /liliStrong understanding of quality processes, including CAPA, change control, deviations and audit preparation. /liliAbility to work independently, manage priorities and deliver practical solutions within a regulated environment. /liliFluent Italian /liliAvailability to work full-time, including three days per week onsite in Milan. /li /ulpbr / /ppIf 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. /ppbr / /ppstrongPlease note: /strong 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. /ppbr / /ppApplications that do not meet these essential requirements will not be considered. /p

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