EU Regulatory Affairs Specialist - Medical Devices

Masimo; Neuenburg; Vor Ort; CHF 100.000 - 150.000; Vollzeit

Zusammenfassung

Masimo International SARL in Neuchâtel, Switzerland seeks a Regulatory Affairs Specialist to support EU regulatory activities and report to the Senior Manager in the UK. The role focuses on EU registrations, submissions, and ensuring compliance across the EU and UK regions.

The successful candidate will own EU registrations, collaborate with international teams, and work from the office. Strong knowledge of CE-marked medical devices and ISO standards is essential.

Qualifikationen

• Experience with EU regulatory requirements for CE-marked medical devices and ISO 13485/EN ISO 14971.
• Excellent English communication skills are required.
• Strong prioritizing, organizational and interpersonal abilities.
• Documentation skills including record maintenance and traceability.
• Ability to work in a team and independently with minimal supervision.
• Self-motivation and disciplined work ethic.
• Proven ability to coordinate with diverse global stakeholders.

Aufgaben

• Prepare and submit national regulatory applications in the EU region.
• Maintain EU registrations/notifications, renewals and changes, including EUDAMED registration.
• Assist in ensuring EU regulatory compliance and maintain regulatory records.
• Maintain EU responsible country regulatory requirements and update documents.
• Maintain regulatory files, lists and ensure up-to-date revisions in systems (SharePoint, Salesforce, Agile PLM).
• Proofread, assemble, route, and archive regulatory registration files.
• Manage renewal schedules for certificates and licenses.
• Prepare distributor letters for distribution agreements and registrations.
• Support global market approvals for product shipments and regulatory meetings.
• Support day-to-day Regulatory Affairs activities and cross-functional coordination.

Kenntnisse

Regulatory knowledge

Verbal and written communication

Attention to detail

Team collaboration

Self-motivated

Ausbildung

Bachelor's degree

Tools

SharePoint

Oracle Agile PLM

Jobbeschreibung

Masimo International SARL in Neuchâtel, Switzerland seeks a Regulatory Affairs Specialist to support EU regulatory activities and report to the Senior Manager in the UK. The role focuses on EU registrations, submissions, and ensuring compliance across the EU and UK regions.

The successful candidate will own EU registrations, collaborate with international teams, and work from the office. Strong knowledge of CE-marked medical devices and ISO standards is essential.