26 set
|
Meet Life Sciences
|
Lazio
26 set
Meet Life Sciences
Lazio
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 ***** 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 *****.
/liliAssess existing quality processes against EU MDR ******** 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 *****,
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 ***** and EU MDR ********.
/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 (Lazio)
🏢 Meet Life Sciences
📍 Lazio