MedTech Regulatory Affairs Specialist OnSite Irvine, Bonus

Danaher Corporation; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Job summary

Masimo, a Danaher operating company, is seeking a Regulatory Affairs Specialist in Irvine, CA to obtain regulatory clearances and ensure compliance for medical devices. The role reports to the Director, Regulatory Affairs and is an on-site position in Irvine.

Responsibilities include drafting 510(k) submissions, coordinating with regional teams, and handling inquiries from health authorities and notified bodies.

Qualifications

• 2+ years in a medical device Class II/III regulatory environment.
• Bachelor’s degree in Engineering or Life Sciences.
• Excellent documentation skills including record maintenance and traceability.
• Familiarity with FDA Class II submissions; GMP knowledge and ISO 13485 is a plus.

Responsibilities

• Support domestic and international filings, including 510(k) notifications and technical files.
• Coordinate with regional teams on product changes and regulatory notifications.
• Communicate with health authorities and notified bodies for filings and inquiries.

Education

Engineering or Life Sciences degree

Job description

Masimo, a Danaher operating company, is seeking a Regulatory Affairs Specialist in Irvine, CA to obtain regulatory clearances and ensure compliance for medical devices. The role reports to the Director, Regulatory Affairs and is an on-site position in Irvine.

Responsibilities include drafting 510(k) submissions, coordinating with regional teams, and handling inquiries from health authorities and notified bodies.