Senior QA/RA Project Lead

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

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: /pullibUrology /b /lilibShock Wave Therapy /b /li /ulpAt EMS, we are driven by our core values: bRespect /b,b Excellence /b,and bClient Orientation /b. Our mission is simple: to ensure bhappy /b and bhealthy patients /b, bsuccessful clinicians /b, andb passionate partners /bthrough the least invasive and clinically proven treatments. /ph3MISSION /h3pAs 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. /ph3RESPONSIBILITIES /h3ulliAct 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 /ulbProduct Development and Design Control /bulliLead 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 /ulbRisk Management and Regulatory Strategy /bulliLead product Risk Management activities in line with ISO 14971, 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 /ulbDocumentation, Quality System and Support /bulliOwn 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 /ulh3PROFILE /h3ulliBachelor'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 /ulh3KEY COMPETENCIES /h3ulliStrong knowledge of medical device regulatory requirements (EU MDR, FDA and international frameworks) and worldwide product registrations. /liliSolid 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). /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 /p #J-18808-Ljbffr

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