Senior Qa/Ra Project Lead
Pubblicato il 09-08-2026 - EMS Italia - Electro Medical Systems in Milano
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:
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Urology
Shock Wave Therapy
At EMS, we are driven by our core values:Respect,Excellence,andClient Orientation.
Our mission is simple: to ensurehappyandhealthy patients,successful clinicians, andpassionate partnersthrough the least invasive and clinically proven treatments.
MISSIONAs 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 R&D;, Product Management, Manufacturing and Supply Chain.
RESPONSIBILITIESAct as the single QA/RA point of contact and lead for the Pain Therapy Business Unit, covering all related development, sustaining and lifecycle projects.
Define, maintain and execute the QA/RA strategy for the Business Unit, aligned with business priorities, product roadmaps and applicable regulatory requirements.
Provide functional QA/RA leadership to cross-functional project teams (R&D;, Product Management, Manufacturing, Supply Chain), without direct hierarchical authority.
Ensure clear ownership, planning, prioritisation and timely completion of all QA/RA deliverables.
Product Development and Design ControlLead and coordinate QA/RA activities throughout product development,
ensuring appropriate QA/RA input into Design Control activities owned by R&D.;
Review and approve relevant Design Control deliverables, and support design reviews, verification & validation strategies, usability, software and electrical safety activities.
Coordinate cybersecurity requirements, risk assessments and documentation for connected medical devices.
Lead QA/RA activities related to Design Transfer, industrialisation and product launch readiness.
Risk Management and Regulatory StrategyLead product Risk Management activities in line with ISO *****, ensuring consistency across risk files, design documentation, clinical evidence and post-market data.
Define worldwide regulatory strategies and pathways for new products, product changes and market expansion.
Lead, prepare and coordinate regulatory submissions and registrations for new and existing products across international markets.
Coordinate responses to authorities and activities involving distributors, consultants and other external partners, and maintain existing product registrations and market access.
Documentation, Quality System and SupportOwn Technical Documentation and product dossiers, ensuring traceability, completeness and ongoing compliance with applicable regulations and standards.
Support internal, external and regulatory audits and inspections,
and contribute to the continuous improvement of the Quality Management System.
Provide QA/RA expertise, training and guidance to internal and external stakeholders, and communicate project status, risks and decisions in a timely manner.
PROFILEBachelor's or Master's degree in Engineering, Life Sciences or another relevant scientific or technical discipline.
7–10 years of demonstrated experience in the medical device industry, preferably with Class IIa and/or Class IIb devices.
Experience with electro-medical devices and medical device software is highly desirable.
Professional certification in Regulatory Affairs, Quality, Risk Management or Project Management is an asset.
Fluent in Italian and English; French is a strong plus.
KEY COMPETENCIESStrong knowledge of medical device regulatory requirements (EU MDR, FDA and international frameworks) and worldwide product registrations.
Solid expertise across ISO ***** (Quality Management Systems), ISO ***** (Risk Management), IEC ***** (medical electrical equipment), IEC ***** (software lifecycle) and IEC ******* (usability engineering).
Hands-on experience with Design Control, Design Reviews, Design Transfer, Technical Documentation and submission dossiers.
Cybersecurity officer/manager competencies for connected medical devices are a strong advantage.
Leadership and influencing skills without direct hierarchical authority, with strong strategic thinking and the ability to translate business objectives into QA/RA priorities.
Excellent communication, cross-functional collaboration and stakeholder management skills in an international environment.
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High level of autonomy, ownership and analytical thinking, with strong organisation, negotiation and continuous improvement mindset.
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