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cms regulatory affairs qms fda healthcare compliance📋 Description
- Lead and grow the Clinical Policy & Regulatory Affairs team.
- Build processes ensuring policy compliance and quality.
- Develop and maintain SOPs, BIPs, and documents aligned with QMS.
- Manage regulatory submissions and regulator interactions (FDA, CMS, state DOIs).
- Deliver executive briefings on regulatory and policy impacts.
- Advise the CMO and senior leaders on compliance risks and strategy.
🎯 Requirements
- Active, unrestricted MD or DO license.
- 10+ years in healthcare or health insurance.
- 5+ years in clinical policy compliance or regulatory/government affairs.
- 5+ years applying health insurance laws (Marketplace, MA, reporting, audits).
- 5+ years preparing and presenting reports to boards of directors.
- 5+ years of team leadership and people development.
🎁 Benefits
- Annual performance bonuses
- Comprehensive benefits: medical, dental, vision
- Unlimited vacation program
- 401(k) plan with company match
- 11 paid holidays and parental leave
- Hybrid work environment with flexible schedule
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