Regulatory Affairs Specialist
Publication date:04 May 2023
Place of work:Neuchâtel
Masimo International SARL headquartered in Neuchâtel, Switzerland, is part of the fast-growing and award-winning international medical technology and device company Masimo Corporation with operations spanning the globe. We develop, market and sell innovative and noninvasive monitoring technologies that save, extend and improve the lives of people of all ages, in all walks of life. For more than 27 years, innovation has been and will continue to be our passion.
Located in the Neuchatel, CH Masimo International Office, the Regulatory Affairs Specialist provides support to the Regulatory Affairs department located at Corporate Headquarters. Key responsibility is to assist with tracking and facilitating external requests for regulatory support, maintain regulatory submission files and registration records, and perform administrative functions as needed by the Global Regulatory Affairs team.
Duties & Responsibilities:
- Preparation and submission of national regulatory applications in the EMEA region
- Process and maintain EMEA registrations, renewals, changes, Free Sale Certificates, and other regulatory certificates
- Assst in ensuring compliance to the MDD/ MDR in the EU and to national requirements in the EMEA region
- Update of the technical documentation taking into account the 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 projects, as needed.
- Perform other duties or special projects as assigned.
- Experienced in regulatory requirements for CE-marked medical devices and medical device requirements for Switzerland requirements and ISO 13485 requirements
- Proficient in Microsoft Office Suite, in particular Outlook, Excel ,Word, and PowerPoint.
- Excellent verbal and written communication skills.
- 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 in a matrix environment with non-local and local leadership
- Excellent English verbal and written communication skills
- 2-5 years of related work experience.
- Proficient in document control systems, such as Microsoft SharePoint and Oracle Agile PLM.
- Prior experience working with international organizations.
- Prior experience working within a medical device company.
Bachelor’s degree, or equivalent combination of education and experience is required. Preferred degrees in science, engineering, 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: www.masimo.com
- Marius Gheorghe