Senior Regulatory & Quality Operations Lead — Medtech

Radiometer; Neuenburg; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Masimo in Neuchâtel, Switzerland, seeks a Sr Manager for Quality and Regulatory Operations to lead regulatory and quality activities ensuring EU and global compliance. You will partner with Commercial, Contracts and cross-functional teams to address tender readiness, regulatory gaps, and documentation needs.

This on-site role focuses on MDR, EUDAMED, UDI, and QMS leadership. The ideal candidate has extensive medtech RA/QA experience, strong ISO 13485 and CAPA proficiency, and hands-on

Qualifikationen

• 8-12+ years in Regulatory Affairs and/or Quality Assurance in medical devices.
• Strong knowledge of EU MDR (2017/745) and CE marking requirements.
• Hands-on EUDAMED and UDI implementation experience.
• Experience with ISO 13485 and CAPA, audits, and change control.
• Fluent in English; other languages a plus.

Aufgaben

• Lead RA/QA operations strategy and execution to support compliance and growth.
• Provide regulatory and quality support for tenders, gap assessments, and documentation.
• Oversee EUDAMED compliance and maintenance of regulatory records.
• Support implementation and maintenance of EU and global UDI frameworks.
• Manage QMS processes, including CAPA, change control, deviations, and audits.

Kenntnisse

Regulatory Affairs

Quality Assurance

EU MDR

EUDAMED

UDI

ISO 13485

CAPA

Audit readiness

Change control

Cross-functional leadership

Jobbeschreibung

Masimo in Neuchâtel, Switzerland, seeks a Sr Manager for Quality and Regulatory Operations to lead regulatory and quality activities ensuring EU and global compliance. You will partner with Commercial, Contracts and cross-functional teams to address tender readiness, regulatory gaps, and documentation needs.

This on-site role focuses on MDR, EUDAMED, UDI, and QMS leadership. The ideal candidate has extensive medtech RA/QA experience, strong ISO 13485 and CAPA proficiency, and hands-on