Senior Scientist responsible for developing and maintaining Core Labeling for pharmaceutical products. Collaborating with global teams to ensure compliance with regulatory requirements and quality standards.
About the role
- Medical Device Audit and Compliance Specialist supporting healthcare providers in compliance and financial recovery. Reviewing documentation and coordinating the return of explanted medical devices.
Responsibilities
- Review client-submitted explant documentation in the +Explants Portal to assess medical device warranty eligibility.
- Identify manufacturer recalls or safety alerts that impact warranty status or require regulatory reporting.
- Coordinate and confirm the timely return of explanted devices to manufacturers for formal evaluation.
- Monitor the status of potential warranty credits and process manufacturer credit reports.
- Identify missing procedures or unreported explants and ensure accurate client follow-up.
- Communicate credit outcomes and compliance updates clearly and professionally to clients.
- Maintain audit-ready documentation and ensure reporting accuracy through the SpendMend +Explants Portal.
Requirements
- Experience in healthcare auditing, compliance, medical device tracking, or a similar field.
- An understanding and willingness to learn Medicare/OIG regulations and medical device warranty processes.
- Experience with product recall tracking and regulatory reporting protocols.
- Exceptional attention to detail, organizational skills, and data accuracy.
- Effective communication skills across clinical, compliance, and administrative teams.
- Proficiency with data entry systems and portals, including the SpendMend +Explants Portal (or similar).
Benefits
- Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of the role.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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