Regulatory Affairs Specialist II

Job description

Job Summary Regulatory Affairs Specialist II is responsible for obtaining and documenting domestic and international regulatory clearances to support the marketing of Masimo products. The individual will be an RA representative on various project teams, providing expert guidance on regulatory requirements to cross-functional teams. For each project, the individual will provide regulatory input to support future regulatory submissions or to ensure compliance of the product to pre-market regulatory clearances. The individual will work closely with Engineering and Marketing team members to understand the technology, marketing and clinical application of each new product. Duties & Responsibilities: Minimum & Preferred Qualifications and Experience - Support the international and domestic filings/registrations, including drafting and compiling of 510(k) Premarket Notifications, Technical Documentation Summaries, and other types of regulatory submissions. - Coordinate with regional regulatory team members on product changes and regulatory notification/ approval requirements. - Assist in communications with regulatory team members to assist in filings and responses to inquiries from healt...