iRhythm Technologies, Inc.
Zio by iRhythm
Director, QA Regulatory Compliance
Location
United States
Posted
40 days ago
Salary
$182K - $237K / year
Bachelor Degree10 yrs expEnglish
Job Description
• Provide regulatory compliance leadership, expertise, and direction to iRhythm teams
• Lead and host regulatory inspections and audits
• Plan, coordinate, and execute end-to-end inspection hosting activities
• Serve as a strategic advisor and thought partner to senior leadership
• Coach and support leaders and teams through high-pressure remediation activities
Job Requirements
- B.A. / B.S. and 10+ years of experience in industry or combined industry and research
- M.A. / M.S. and 8+ years of experience in industry or combined industry and research
- Demonstrated leadership in FDA remediation and enforcement resolution
- Strong knowledge of 21 CFR Part 820, ISO 13485, EU MDR, UK MDR regulations
- Proven experience influencing cross-functional teams in a matrixed organization
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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