Senior QA/RA Project Lead

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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:
Urology
Shock Wave Therapy
MISSION 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 R&D;, Product Management, Manufacturing and Supply Chain.
RESPONSIBILITIES 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.
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 Control Lead 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 Strategy Lead product Risk Management activities in line with ISO 14971, ensuring consistency across risk files, design documentation, clinical evidence and post

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7emmvj