Regulatory Affairs Specialist

Danaher•Irvine, CA

1d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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 Degree

Responsibilities

Obtain domestic and internal regulatory clearances for Masimo products to meet business objectives.
Provide 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.
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.