Specialist, Regulatory Affairs

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

JOB DESCRIPTION

Based at Masimo International SARL in Neuchâtel, Switzerland, the Regulatory Affairs Specialist will provide essential support to the EU Regulatory Affairs team reporting directly to the Senior Manager based in UK.

Job Summary

Based at Masimo International SARL in Neuchâtel, Switzerland, the Regulatory Affairs Specialist will provide essential support to the EU Regulatory Affairs team reporting directly to the Senior Manager based in UK.

This is an exciting opportunity for a self-motivated and due diligent regulatory professional to contribute to the successful registration and commercialization of Masimo’s innovative medical technologies across the EU and UK region. The successful candidate will take 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. The successful candidate is expected to work from the office.

Duties & Responsibilities

• 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
• Assist in ensuring compliance with EU and national requirements in the EU region
• Maintain EU responsible country regulatory requirements
• Maintain regulatory affairs files and listing and distribute information as required
• Proofread, assemble, route, and archive regulatory registration files, as directed.
• Maintain schedule for renewal of regulatory certificates and licenses.
• 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.
• Assess impact of change to Medical Devices in respect of national regulatory requirements
• Support customer service, marketing, and sales with global market approvals for product shipments.
• Support scheduling and arrangements for regulatory meetings.
• Support Regulatory Affairs team with day-to-day tasks, as needed
• Perform other duties or special projects as assigned.

Minimum Qualifications

• Experienced in EU regulatory requirements for CE-marked medical devices and ISO 13485 and EN ISO 14971 requirements
• Proficient in Microsoft Office Suite, in particular Outlook, Excel ,Word, and PowerPoint.
• Excellent verbal and written communication skills. (English essential)
• Excellent prioritizing, organizational and interpersonal skills.
• Excellent documentation skills including record maintenance/ tracking and understanding of document traceability.
• A detailed-oriented individual with a "can do" attitude and ability to work in a team environment as well as individually with minimal supervision
• Self-motivated and disciplined
• Demonstrated ability to work with non-local and local leadership

Preferred Qualifications

• 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.
• Prior experience working with international corporations.
• Experience in global regulatory such as FDA, UKCA and other

Education

Bachelor's degree, or equivalent combination of education and experience is required. Preferred degrees in life sciences, engineering, law and medical/healthcare.

To learn more about us, please visit: www.masimo.com