Regulatory Affairs Specialist

Regulatory Affairs Specialist is responsible for obtaining and documenting our mission-critical, Indian regulatory clearances for Masimo’s amazing innovative medical device products. The individual will be the sole RA representative on various project teams for new products or product changes. The individual will provide regulatory assessment according to local regulations for medical device, IT equipment, etc. in parallel and on different schedules, the individual must have excellent organizational and multitasking skills. During the project life cycle, the individual will be primarily responsible for preparing and filing Indian registration or certification submissions by their deadlines. This preparation requires a detail-oriented, meticulous, and diligent approach. Moreover, the individual must take ownership of that preparation and work with various Engineering, Marketing and other team members to finalize the submission.