pb ABOUT EMS /bp Scorra verso il basso per trovare i dettagli completi dell'offerta, inclusa l'esperienza richiesta e le mansioni associate.
brp EMS 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: /p ullib Dental Prevention /b /lilib Urology /b /lilib Shock Wave Therapy /b /li /ul p At EMS, we are driven by our core values: b Respect /b , b Excellence /b ,and b Client Orientation /b .
Our mission is simple: to ensure b happy /b and b healthy patients /b , b successful clinicians /b , and b passionate partners /b through the least invasive and clinically proven treatments.
/p pb MISSION /b /p p As 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.
/p pb RESPONSIBILITIES /b /p pb QA/RA Leadership /b /p ulli Act as the single QA/RA point of contact and lead for the Pain Therapy Business Unit, covering all related development, sustaining and lifecycle projects.
/lili Define, maintain and execute the QA/RA strategy for the Business Unit, aligned with business priorities, product roadmaps and applicable regulatory requirements.
/lili Provide functional QA/RA leadership to cross-functional project teams (RD, Product Management, Manufacturing, Supply Chain), without direct hierarchical authority.
/lili Ensure clear ownership, planning, prioritisation and timely completion of all QA/RA deliverables.




/li /ul pb Product Development and Design Control /b /p ulli Lead and coordinate QA/RA activities throughout product development, ensuring appropriate QA/RA input into Design Control activities owned by RD.
/lili Review and approve relevant Design Control deliverables, and support design reviews, verification validation strategies, usability, software and electrical safety activities.
/lili Coordinate cybersecurity requirements, risk assessments and documentation for connected medical devices.
/lili Lead QA/RA activities related to Design Transfer, industrialisation and product launch readiness.
/li /ul pb Risk Management and Regulatory Strategy /b /p ulli Lead product Risk Management activities in line with ISO *****, ensuring consistency across risk files, design documentation, clinical evidence and post-market data.
/lili Define worldwide regulatory strategies and pathways for new products, product changes and market expansion.
/lili Lead, prepare and coordinate regulatory submissions and registrations for new and existing products across international markets.
/lili Coordinate responses to authorities and activities involving distributors, consultants and other external partners, and maintain existing product registrations and market access.
/li /ul pb Documentation, Quality System and Support /b /p ulli Own Technical Documentation and product dossiers, ensuring traceability, completeness and ongoing compliance with applicable regulations and standards.
/lili Support internal, external and regulatory audits and inspections, and contribute to the continuous improvement of the Quality Management System.




/lili Provide QA/RA expertise, training and guidance to internal and external stakeholders, and communicate project status, risks and decisions in a timely manner.
/li /ul pb PROFILE /b /p ulli Bachelor'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.
/lili Experience with electro-medical devices and medical device software is highly desirable.
/lili Professional certification in Regulatory Affairs, Quality, Risk Management or Project Management is an asset.
/lili Fluent in Italian and English; French is a strong plus.
/li /ul pb KEY COMPETENCIES /b /p ulli Strong knowledge of medical device regulatory requirements (EU MDR, FDA and international frameworks) and worldwide product registrations.
/lili Solid expertise across ISO ***** (Quality Management Systems), ISO ***** (Risk Management), IEC ***** (medical electrical equipment), IEC ***** (software lifecycle) and IEC ******* (usability engineering).
/lili Hands-on experience with Design Control, Design Reviews, Design Transfer, Technical Documentation and submission dossiers.
/lili Cybersecurity officer/manager competencies for connected medical devices are a strong advantage.
/lili Leadership and influencing skills without direct hierarchical authority, with strong strategic thinking and the ability to translate business objectives into QA/RA priorities.
/lili Excellent communication, cross-functional collaboration and stakeholder management skills in an international environment.
xrdbqlu /lili High level of autonomy, ownership and analytical thinking, with strong organisation, negotiation and continuous improvement mindset.
/li /ul /p /p

📌 Senior Qa/Ra Project Lead (Milano)
🏢 EMS Italia - Electro Medical Systems
📍 Milano