5802- MedTech Compliance Program SME / Quality/GxP Auditor
Skills
- Experience with US Healthcare Compliance and related regulations (AdvaMed Code, OIG, Sunshine Act, AKS)
- Proven ability to create and deploy SOPs and training frameworks
- Strong technical writing skills for regulatory documents
- Proficiency with Excel, Word, DocuSign, LMS, and SharePoint
- Ability to manage cross-geography teams and projects
- Experience with medical device regulatory frameworks (FDA Class II or III)
Responsibilities
- Map existing practices to ensure compliance with healthcare regulations
- Identify and remediate gaps in SOPs, policies, and compliance frameworks
- Develop core SOPs, logs, and compliance tracking documents
- Incorporate compliance materials into training and onboarding programs
- Advise and provide guidance during Compliance Committee meetings
- Maintain documentation and readiness for internal and external audits
Education
- Bachelor's Degree in life sciences regulatory affairs, business or healthcare compliance
- Certifications such as CHC (HCCA), RAPS, or Greenlight Guru medical device QA/RA programs
Benefits
- Competitive pay plus performance-based incentives
- Company-paid Life, Short-Term, and Long-Term Disability Insurance
- Medical, Dental & Vision insurance
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan with employer match
- Paid Time Off with rollover option and holidays
- Sick Time as needed
- Tuition Reimbursement
- Team Social Activities and Employee Recognition programs
- Employee Referral Program
- Paid Parental Leave and Bereavement
Average salary estimate
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