p ABOUT EMS p 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: /pulli Dental Prevention /lili Urology /lili Shock Wave Therapy /li /ulp At EMS, we are driven by our core values: Respect, Excellence, and Client Orientation. Our mission is simple: to ensure happy and healthy patients, successful clinicians, and passionate partners through the least invasive and clinically proven treatments. /pp MISSION /pp 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. /pp RESPONSIBILITIES /pp QA/RA Leadership /pulli 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 /ulp Product Development and Design Control /pulli 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 /ulp Risk Management and Regulatory Strategy /pulli Lead product Risk Management activities in line with ISO 14971, 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 /ulp Documentation, Quality System and Support /pulli 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 /ulp PROFILE /pulli 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 /ulp KEY COMPETENCIES /pulli Strong knowledge of medical device regulatory requirements (EU MDR, FDA and international frameworks) and worldwide product registrations. /lili Solid expertise across ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), IEC 60601 (medical electrical equipment), IEC 62304 (software lifecycle) and IEC 62366-1 (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. /lili High level of autonomy, ownership and analytical thinking, with strong organisation, negotiation and continuous improvement mindset. /li /ul /p

📌 Senior QA/RA Project Lead (Lombardia)
🏢 EMS Italia - Electro Medical Systems
📍 Lombardia