MedTech RA/QA Operations Lead — EU MDR & EUDAMED

Masimo; Neuenburg; On-site; CHF 120,000 - 160,000; Full time

Job summary

Masimo, a leading medical technology company, seeks a Sr Manager for Quality & Regulatory Operations to lead regulatory and quality activities supporting compliance, market access, and commercial success. The role is on-site in Neuchâtel, Switzerland, reporting to the Sr Director of Quality & Regulatory Strategy.

You will partner with Commercial, Contracts, and cross-functional teams to support tender readiness, interpret regulatory requirements, identify gaps, and implement practical solutions

Qualifications

• 8–12+ years in Regulatory Affairs and/or Quality Assurance within the medical device industry.
• Strong knowledge of EU MDR (2017/745), CE marking requirements, and European regulatory frameworks.
• Hands-on experience with EUDAMED and UDI implementation in alignment with global frameworks.
• Strong experience in Quality Management Systems (ISO 13485), including CAPA, audits, change control, and compliance processes.
• Fluent in English, any other language is a plus.

Responsibilities

• Lead RA/QA operations strategy and execution to support compliance and business growth.
• Oversee regulatory and quality support for tenders, including requirement review, gap assessment, and compliant documentation.
• Oversee EUDAMED compliance (actor registration, device data, vigilance) and support maintenance of regulatory records.
• Support implementation and maintenance of UDI frameworks, ensuring alignment with EU and global UDI requirements.
• Manage and improve Quality Management System (QMS) processes, including CAPA, change control, deviations, and audit readiness.

Skills

Regulatory Affairs

Quality Assurance

ISO 13485

EU MDR

EUDAMED

UDI

CAPA

Audits

Leadership

Job description

Masimo, a leading medical technology company, seeks a Sr Manager for Quality & Regulatory Operations to lead regulatory and quality activities supporting compliance, market access, and commercial success. The role is on-site in Neuchâtel, Switzerland, reporting to the Sr Director of Quality & Regulatory Strategy.

You will partner with Commercial, Contracts, and cross-functional teams to support tender readiness, interpret regulatory requirements, identify gaps, and implement practical solutions