Regulatory Affairs Specialist

Regulatory Affairs SpecialistBring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Masimo, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact.You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is, Masimo innovations empower clinicians to transform patient care. When you join our team, you'll be part of a culture that's driven by passion, challenging the status quo, and making an impact in the lives of others.Learn about the Danaher Business System which makes everything possible.The Regulatory Affairs Specialist is responsible for obtaining domestic and internal regulatory clearances for Masimo products to meet business objectives. The individual will be capable of providing supported regulatory assessments of medical device regulations to help effective application of regulatory requirements to future products to ensure compliance of the product to pre-market regulatory clearances.This position reports to the Director, Regulatory Affairs and is part of the Regulatory Affairs team located in Irvine, CA and will be an on-site role.In this role, you will have the opportunity to:Support the regulatory team managing international and domestic filings/registrations, including drafting and compiling of 510(k) Premarket Notifications, technical files, STED Documents and related submissions.Coordinate with regional regulatory team members on product changes and regulatory notification / approval requirements.Assist in communications with regional regulatory representatives to assist in filings and responses to inquiries from health authorities and notified bodies worldwide.The essential requirements of the job include:2+ years of work experience in a medical device Class II/ III environment.Bachelor's degree is required, preferably in Engineering or Life Sciences.Excellent documentation skills including record maintenance/ tracking and understand document traceability.It would be a plus if you also possess previous experience in:Regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission.FDA/GMP requirements for medical device.Quality Systems per ISO 13485.Graduate DegreeMasimo, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.The annual salary range for this role is $80,000 - $100,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.This job is also eligible for bonus/incentive pay.We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. Sendx Medical, Inc.