Regulatory Affairs Specialist - Medical Devices (On-Site)

Masimo Corporation; Irvine (CA); Vor Ort; USD 80.000 - 100.000; Vollzeit

Benefits dieser Stelle

Bonus & Incentives

Zusammenfassung

Masimo Corporation in Irvine, CA is seeking a Regulatory Affairs Specialist to obtain domestic and internal regulatory clearances for medical devices, ensuring compliance with FDA and ISO 13485 standards. This on-site role reports to the Director, Regulatory Affairs and involves coordinating filings (510(k)), communicating with regional authorities, and maintaining thorough documentation.

A Bachelor’s in Engineering or Life Sciences and 2+ years in Class II/III device environments are required,

Qualifikationen

• 2+ years of experience in a medical device Class II/III environment.
• Bachelor's degree in Engineering or Life Sciences is required.
• Excellent documentation and record-keeping skills.

Aufgaben

• Support filings such as 510(k) notifications, technical files, STED docs and related submissions.
• Coordinate with regional teams on product changes and regulatory requirements.
• Assist in communications with regional authorities for filings and inquiries.

Kenntnisse

Regulatory submissions

Regulatory communications

Documentation & traceability

Ausbildung

Bachelor's degree in Engineering or Life Sciences

Jobbeschreibung

Masimo Corporation in Irvine, CA is seeking a Regulatory Affairs Specialist to obtain domestic and internal regulatory clearances for medical devices, ensuring compliance with FDA and ISO 13485 standards. This on-site role reports to the Director, Regulatory Affairs and involves coordinating filings (510(k)), communicating with regional authorities, and maintaining thorough documentation.

A Bachelor’s in Engineering or Life Sciences and 2+ years in Class II/III device environments are required,