Senior QA/RA Project Lead

EMS Italia - Electro Medical Systems; Milano; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

EMS Italia - Electro Medical Systems in Milano seeks an experienced QA/RA leader to guide regulatory strategy and quality activities across the full product lifecycle for Pain Therapy devices. You will collaborate with R&D, Product Management, Manufacturing and Supply Chain to ensure compliant development, lifecycle management and market access.

The role requires 7–10 years in the medical device field, expertise with ISO 13485/14971, and fluency in Italian and English (French a plus).

Competenze

• Bachelor'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 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.

Mansioni

• 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.

Conoscenze

Regulatory leadership

Cross-functional collaboration

Italian language

English language

French language (a strong plus)

Formazione

Bachelor's or Master's in Engineering or Life Sciences

Strumenti

ISO 13485

ISO 14971

IEC 60601

IEC 62304

IEC 62366-1

Regulatory submissions

Descrizione del lavoro

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

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.

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-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 Support

• Own 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.

PROFILE

• Bachelor'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 COMPETENCIES

• Strong knowledge of medical device regulatory requirements (EU MDR, FDA and international frameworks) and worldwide product registrations.
• 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).
• 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.
• High level of autonomy, ownership and analytical thinking, with strong organisation, negotiation and continuous improvement mindset.