Pay Rate: €30 per hourbrSe pensa di essere il profilo ideale per la seguente possibilità, si candidi dopo aver letto la descrizione completa.brLocation:brMilan, Italy | Hybrid – 3 days onsite per weekbrContract:brFull-timebrIndustry:brDental Medical DevicesbrLanguage:brFluent Italian requiredbrMeet 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.brWe 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.brThe 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.brThis 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.brKey ResponsibilitiesbrSupport the implementation, maintenance and continuous improvement of Quality Management Systems in accordance with ISO 13485.brAssess existing quality processes against EU MDR 2017/745 requirements, identifying compliance gaps and supporting corrective actions.brPrepare, review and maintain technical documentation to support medical device regulatory compliance.brSupport internal and external audits, including preparation for notified body assessments.brReview and improve quality procedures, SOPs, CAPA processes, deviations and change control activities.brSupport risk management activities in accordance with ISO 14971,



ensuring appropriate integration with quality and regulatory processes.brCollaborate with Quality Assurance, Regulatory Affairs, Engineering and Manufacturing teams to ensure consistent application of regulatory requirements.brProvide practical guidance on quality and regulatory matters relating to dental medical devices.brSupport the development and implementation of corrective actions to address identified quality and regulatory compliance gaps.brCandidate Requirements:brDemonstrable experience in Quality Assurance, Regulatory Affairs or QMS consultancy within the medical device industry.brStrong working knowledge of ISO 13485 and EU MDR 2017/745.brPrevious experience working directly with dental medical devices or dental device manufacturers.brHands-on experience implementing, maintaining or improving medical device Quality Management Systems.brExperience preparing or reviewing technical documentation and supporting regulatory compliance activities.brStrong understanding of quality processes, including CAPA, change control, deviations and audit preparation.brAbility to work independently, manage priorities and deliver practical solutions within a regulated environment.brFluent ItalianbrAvailability to work full-time, including three days per week onsite in Milan.brIf 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.brPlease note:brApplicants 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. xjncmbx brApplications that do not meet these essential requirements will not be considered.

📌 Dental Medical Device QMS / MDR Consultant (Milano)
🏢 Meet Life Sciences
📍 Milano