Regulatory Affairs Specialist

Danaher Corporation • Irvine, CA

6d • $80,000 - $100,000 • Onsite

About The Position

The Regulatory Affairs Specialist obtains domestic and international regulatory clearances for Masimo products in support of business objectives. The role provides supported regulatory assessments of medical device regulations and helps apply regulatory requirements to future products to ensure compliance with pre-market regulatory clearances.

This position is part of the Regulatory Affairs team in Irvine, California, reports to the Director, Regulatory Affairs, and is performed onsite.

Requirements

• At least 2 years of work experience in a medical device Class II/III environment.
• Bachelor’s degree, preferably in Engineering or Life Sciences.
• Excellent documentation skills, including record maintenance and tracking, and understanding of document traceability.

Nice To Haves

• Experience with regulatory submission requirements for FDA Class II medical devices and equivalent classification requirements for international submissions.
• Experience with FDA/GMP requirements for medical devices.
• Experience with Quality Systems per ISO 13485.
• Graduate degree.

Responsibilities

• Support the regulatory team in managing international and domestic filings and registrations, including drafting and compiling 510(k) Premarket Notifications, technical files, STED documents, and related submissions.
• Coordinate with regional regulatory team members on product changes and regulatory notification and approval requirements.
• Assist with communications with regional regulatory representatives to support filings and responses to inquiries from health authorities and notified bodies worldwide.

Benefits

• Paid time off
• Medical insurance
• Dental insurance
• Vision insurance
• 401(k)
• Bonus/incentive pay targeted at 10% of annual base salary

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level