Sr Manager, Quality and Regulatory Operations

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

About the Company

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Masimo, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions.

Our mission is, Masimo innovations empower clinicians to transform patient care. When you join our team, you’ll be part of a culture that’s driven by passion, challenging the status quo, and making an impact in the lives of others. Learn about the Danaher Business System which makes everything possible.

About the Role

The Sr Manager, Quality and Regulatory Operations will lead regulatory and quality operations to support compliance, market access, and commercial success. This role combines regulatory expertise with quality systems leadership to ensure products, processes, and documentation meet EU and global requirements.

The individual will act as a key partner to Commercial, Contracts, and cross-functional teams to support tender readiness, interpret regulatory and quality requirements, identify gaps, and implement practical solutions.

This role requires strong expertise in medical device regulatory frameworks, quality systems, labeling, and post-market compliance, along with the ability to drive operational excellence and audit readiness.

This position reports to the Sr Director, Quality & Regulatory Strategy and is part of the Quality Compliance team located in Neuchâtel, Switzerland and will be an on-site role.

Key Responsibilities

In this role, you will have the opportunity to:

• Lead RA/QA operations strategy and execution to support compliance and business growth
• Drive 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

Required qualifications

The essential requirements of the job include:

• 8-12+ years of experience 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.

Preferred qualifications

It would be a plus if you also possess previous experience in:

• Patient monitoring, hospital-based medical devices, digital health, or software-enabled medical technologies
• 3-5+ years of people leadership or matrix leadership experience, including mentoring and influencing cross-functional teams
• Working in EU-focused or global medtech organizations with exposure to multi-country quality and regulatory operations

Benefits

Masimo, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.