Dental Medical Device QMS / MDR Consultant

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8261vm

pbPay Rate: €30 per hour /b /ppbLocation: /b Milan, Italy | Hybrid – 3 days onsite per week /ppbContract: /b Full-time /ppbIndustry: /b Dental Medical Devices /ppbLanguage: /b 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/ppbKey Responsibilities /b /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/ppbCandidate Requirements: /b /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/ppbPlease note: /b 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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8261vm