MedTech Compliance SME

Job Summary

A company is looking for a MedTech Compliance Program SME / Quality/GxP Auditor.

Key Responsibilities

• Map existing practices to ensure compliance and identify gaps in established documents
• Develop core SOPs and policies to remediate content gaps and incorporate them into training programs
• Provide guidance during quarterly Compliance Committee meetings and ensure readiness for compliance inquiries

Required Qualifications and Education

• Experience with US Healthcare Compliance, including familiarity with AdvaMed Code and Anti-Kickback Statute
• Experience with commercial, clinical, or regulatory frameworks in medical devices, preferably FDA Class II or III
• Bachelor's Degree in life sciences regulatory affairs, business, or healthcare compliance
• Certification from HCCA, RAPS, or related medical device QA/RA programs
• Proficiency in Excel, Word, and platforms like DocuSign, LMS, or SharePoint