Manager, Quality & Regulatory Operations

Radiometer; Neuenburg; Presencial; CHF 140.000 - 190.000; Jornada completa

Descripción de la vacante

Masimo Neuchâtel, Switzerland, seeks a Manager of Quality & Regulatory Operations to lead regulatory and quality activities on-site. You will partner with Commercial, Contracts, and cross-functional teams to ensure compliance and market access for EU and global medical devices.

The role requires deep knowledge of EU MDR, ISO 13485, EUDAMED, and UDI, with strong CAPA and audit experience. Fluency in English is essential; this on-site position offers a dynamic environment driving regulatory

Formación

• 4–6+ years of experience in regulatory affairs and/or quality assurance in medical devices.
• Strong knowledge of EU MDR (2017/745) and CE marking.
• Hands-on experience with EUDAMED and UDI implementation.
• Experience with ISO 13485, CAPA, audits, and change control.

Responsabilidades

• Lead RA/QA operations to support compliance and market access.
• Collaborate with cross-functional teams to prepare tenders and regulatory submissions.
• Ensure EU and global regulatory alignment and maintain regulatory records.
• Support implementation and maintenance of QMS processes, including CAPA and audits.

Conocimientos

Regulatory affairs

Quality assurance

EU MDR

EUDAMED

UDI

ISO 13485

CAPA

Audit readiness

English (Fluent)

Descripción del empleo

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.

The Manager, Quality & 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 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.

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

The essential requirements of the job include:

• 4-6+ 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.

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

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.