Director, QA Regulatory Compliance
iRhythm Technologies, Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $182,000 - $237,000 per year
Job Level
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory complianceFDA remediationenforcement resolution21 CFR Part 820ISO 13485EU MDRUK MDR
Soft Skills
leadershipstrategic advisingcoachingsupporting teamsinfluencing cross-functional teams