Regulatory Affairs Specialist

仕事内容

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 and collaborate closely with colleagues in a different time zone for occasional meetings and discussions held outside standard Swiss office hour. 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. Are you looking for uncommon opportunities with an extraordinary company? We are looking for people who can, do and will make a difference. Are you interested to hear more about this position? Please send your full application. To learn more about us, please visit: Regulatory Affairs Specialist 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 and collaborate closely with colleagues in a different time zone for occasional meetings and discussions held outside standard Swiss office hour. 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. Are you looking for uncommon opportunities with an extraordinary company? We are looking for people who can, do and will make a difference. Are you interested to hear more about this position? Please send your full application. 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