Job Description

Regulatory Affairs Specialist at Masimo, a Danaher medical technology company, manages domestic and international regulatory clearances for medical devices. The role involves preparing submissions, coordinating with regional teams, and ensuring compliance with regulatory requirements.

Responsibilities

• Support regulatory team with international and domestic filings including 510(k) premarket notifications and technical files
• Coordinate with regional regulatory team members on product changes and notification requirements
• Assist with health authority communications and responses to inquiries from regulatory bodies worldwide

Requirements

• 2+ years experience in Class II/III medical device environments
• Bachelor's degree, preferably in Engineering or Life Sciences
• Excellent documentation, record maintenance, and traceability skills
• FDA Class II submission and international classification knowledge preferred
• FDA/GMP and ISO 13485 quality systems knowledge preferred
• Graduate degree preferred

Compensation: $80,000-$100,000 base plus 10% target bonus

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