Senior Qa/Ra Project Lead

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79qfc2

pstrongABOUT EMS /strong /ppbr/ppEMS is a global leader in the design, manufacturing, and sale of devices used for medical and dental treatments.
With over 40 years of expertise, EMS embodies Swiss precision and craftsmanship, delivering innovative solutions in: /ppbr/pullistrongDental Prevention /strong /lilistrongUrology /strong /lilistrongShock Wave Therapy /strong /li /ulpbr/ppAt EMS, we are driven by our core values: strongRespect /strong,strong Excellence /strong, and strongClient Orientation /strong.
Our mission is simple: to ensure stronghappy /strong and stronghealthy patients /strong, strongsuccessful clinicians /strong, andstrong passionate partners /strongthrough the least invasive and clinically proven treatments.
/ppbr/ppstrong MISSION /strong /ppbr/ppAs the primary Quality and Regulatory Affairs representative for the Pain Therapy Business Unit, you will provide strategic and operational QA/RA leadership across the full product lifecycle — from concept and development through market access, post-market activities and lifecycle management — in close collaboration with RD, Product Management, Manufacturing and Supply Chain.
/ppbr/ppstrongRESPONSIBILITIES /strong /ppbr/ppstrongemQA/RA Leadership /em /strong /ppbr/pulliAct as the single QA/RA point of contact and lead for the Pain Therapy Business Unit, covering all related development, sustaining and lifecycle projects.
/liliDefine, maintain and execute the QA/RA strategy for the Business Unit, aligned with business priorities, product roadmaps and applicable regulatory requirements.
/liliProvide functional QA/RA leadership to cross-functional project teams (RD, Product Management, Manufacturing, Supply Chain), without direct hierarchical authority.
/liliEnsure clear ownership, planning, prioritisation and timely completion of all QA/RA deliverables.




/li /ulpbr/ppstrongemProduct Development and Design Control /em /strong /ppbr/pulliLead and coordinate QA/RA activities throughout product development, ensuring appropriate QA/RA input into Design Control activities owned by RD.
/liliReview and approve relevant Design Control deliverables, and support design reviews, verification validation strategies, usability, software and electrical safety activities.
/liliCoordinate cybersecurity requirements, risk assessments and documentation for connected medical devices.
/liliLead QA/RA activities related to Design Transfer, industrialisation and product launch readiness.
/li /ulpbr/ppstrongemRisk Management and Regulatory Strategy /em /strong /ppbr/pulliLead product Risk Management activities in line with ISO *****, ensuring consistency across risk files, design documentation, clinical evidence and post-market data.
/liliDefine worldwide regulatory strategies and pathways for new products, product changes and market expansion.
/liliLead, prepare and coordinate regulatory submissions and registrations for new and existing products across international markets.
/liliCoordinate responses to authorities and activities involving distributors, consultants and other external partners, and maintain existing product registrations and market access.
/li /ulpbr/ppstrongem Documentation, Quality System and Support /em /strong /ppbr/pulliOwn Technical Documentation and product dossiers, ensuring traceability, completeness and ongoing compliance with applicable regulations and standards.
/liliSupport internal, external and regulatory audits and inspections,



and contribute to the continuous improvement of the Quality Management System.
/liliProvide QA/RA expertise, training and guidance to internal and external stakeholders, and communicate project status, risks and decisions in a timely manner.
/li /ulpbr/ppstrong PROFILE /strong /ppbr/pulliBachelor's or Master's degree in Engineering, Life Sciences or another relevant scientific or technical discipline.
/lili7–10 years of demonstrated experience in the medical device industry, preferably with Class IIa and/or Class IIb devices.
/liliExperience with electro-medical devices and medical device software is highly desirable.
/liliProfessional certification in Regulatory Affairs, Quality, Risk Management or Project Management is an asset.
/liliFluent in Italian and English; French is a strong plus.
/li /ulpbr/ppstrongKEY COMPETENCIES /strong /ppbr/pulliStrong knowledge of medical device regulatory requirements (EU MDR, FDA and international frameworks) and worldwide product registrations.
/liliSolid expertise across ISO ***** (Quality Management Systems), ISO ***** (Risk Management), IEC ***** (medical electrical equipment), IEC ***** (software lifecycle) and IEC ******* (usability engineering).
/liliHands-on experience with Design Control, Design Reviews, Design Transfer, Technical Documentation and submission dossiers.
/liliCybersecurity officer/manager competencies for connected medical devices are a strong advantage.
/liliLeadership and influencing skills without direct hierarchical authority, with strong strategic thinking and the ability to translate business objectives into QA/RA priorities.
/liliExcellent communication, cross-functional collaboration and stakeholder management skills in an international environment.
/liliHigh level of autonomy, ownership and analytical thinking, with strong organisation, negotiation and continuous improvement mindset.
/li /ul

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79qfc2