Specialist, Regulatory Affairs

Masimo; Neuenburg; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Masimo Neuchâtel is seeking a Regulatory Affairs Specialist to own EU product registrations, ensuring compliance with EU regulatory requirements and timely submissions. You will work with cross-functional teams within a global organization and report to the Regulatory Senior Manager.

The role is on-site in Neuchâtel, Switzerland, focusing on EU region registrations, notifications, and changes, with responsibilities spanning document control and collaboration with global regulatory teams.

Qualifikationen

• Experience with CE-marked medical devices and ISO 13485/EN ISO 14971 requirements.
• 2–5 years EU regulatory work experience in a medical device company.
• Proficient in document control systems such as SharePoint and Oracle Agile PLM.
• Experience in global regulatory (FDA, UKCA and others) is a plus.

Aufgaben

• Prepare and submit national/regional EU regulatory applications.
• Process and maintain EU registrations/notifications, renewals, changes, etc.
• Process distributor letters for distribution agreements and authorizations to register.
• Maintain regulatory records in SharePoint, Salesforce, and Agile PLM.
• Support customer service, marketing, and sales with global market approvals.

Kenntnisse

EU regulatory knowledge

Regulatory submissions

Cross-functional collaboration

Documentation management

Tools

SharePoint

Oracle Agile PLM

Jobbeschreibung

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 Specialist, Regulatory Affairs is responsible fortaking ownership of EU regional product registrations, ensuring that regulatory requirements are effectively managed and that submissions and registrations are completed accurately and within established timelines. Working within a highly collaborative, international organization, the Regulatory Affairs Specialist will liaise closely with cross functional stakeholders as well as regulatory affairs associates across EU and wider global regulatory affairs teams.

This position reports to the Sr Manager, Regulatory and is part of the Regulatory Affairs team located in Neuchâtel, Switzerland and will be an on-site role.

In this role, you will have the opportunity to:

• Preparation and submission of national regulatory applications in the EU region
• Process and maintain EU registrations/notifications, renewals, changes, other regulatory activities such as EUDAMED registration
• Process and maintain requests to complete distributor letters for: distribution agreements, power of attorney, authorizations to register, product lists, market history, etc.
• Maintain published regulatory records and databases in SharePoint, Salesforce and company document control system (Agile PLM) to ensure latest regulatory approved revisions are presented.
• Support customer service, marketing, and sales with global market approvals for product shipments.

The essential requirements of the job include:

• Experienced in EU regulatory requirements for CE-marked medical devices and ISO 13485 and EN ISO 14971 requirements
• 2-5 years of EU regulatory work experience in a medical device company.
• Proficient in document control systems, such as SharePoint and Oracle Agile PLM.
• Experience in global regulatory such as FDA, UKCA and other

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

• Prior experience working with international corporations.
• Demonstrating ability to work with non-local and local leadership
• Documentation skills including record maintenance/ tracking and understanding of document traceability.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. 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.