Senior QA/RA Operations Leader — MedTech Compliance & UDI

Danaher Corporation; Neuenburg; On-site; CHF 120,000 - 180,000; Full time

Job summary

Masimo, part of the Danaher family, seeks a Sr Manager of Quality & Regulatory Operations in Neuchâtel to lead regulatory and quality activities ensuring EU and global compliance. You will partner with Commercial, Contracts, and cross-functional teams to close gaps and implement practical solutions.

Your role requires deep regulatory knowledge, quality systems leadership, and the ability to drive operational excellence and post-market compliance in a fast-paced environment.

Qualifications

• 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 experience with EUDAMED and UDI implementation.
• Experience with ISO 13485, CAPA, audits, change control and compliance processes.
• Fluent in English; additional languages are a plus.

Responsibilities

• Lead RA/QA operations to support regulatory compliance and business growth.
• Provide regulatory and quality support for tenders, including gap assessments and compliant documentation.
• Oversee EUDAMED and UDI compliance activities and maintain regulatory records.
• Drive QMS improvements and ensure audit readiness across the organization.

Skills

Regulatory Affairs

Quality Assurance

EU MDR

EUDAMED

UDI

ISO 13485

CAPA & Change Control

Audit Readiness

English Fluent

Job description

Masimo, part of the Danaher family, seeks a Sr Manager of Quality & Regulatory Operations in Neuchâtel to lead regulatory and quality activities ensuring EU and global compliance. You will partner with Commercial, Contracts, and cross-functional teams to close gaps and implement practical solutions.

Your role requires deep regulatory knowledge, quality systems leadership, and the ability to drive operational excellence and post-market compliance in a fast-paced environment.