Regulatory Affairs Specialist
$80k - $100kDanaher Corporation Office Usa
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
Vacancy posted 4 days ago
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