Assist with the preparation, submission, and tracking of state and federal licensing applications and renewals.
Maintain organized records of licensing documentation and correspondence.
Ensure compliance with applicable laws and regulations, including: FDA regulations (21 CFR Part 820), State medical device distributor licensing requirements, Anti-Kickback Statute and Stark Law considerations for service arrangements.
Support data collection and validation for Open Payments (Sunshine Act) reporting.
Collaborate with internal stakeholders to ensure accurate and timely reporting of transfers of value to healthcare professionals.
Assist in reconciling payment data and preparing documentation for audit readiness.
Analyze current administrative and compliance workflows to identify inefficiencies.
Propose and document process improvements to enhance accuracy, timeliness, and scalability.
Support the development of SOPs and training materials for revised processes.
Assist in monitoring activities to ensure adherence to internal policies and external regulations.
Participate in compliance-related projects, including risk assessments and training initiatives.
Help maintain documentation for audits, inspections, and internal reviews.
Requirements
Currently pursuing a Bachelor's degree in Business, Healthcare Administration, Legal Studies, or a related field.
Strong organizational skills and attention to detail.
Excellent written and verbal communication skills.
Ability to handle confidential information with discretion.
Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).
Interest in healthcare compliance, regulatory affairs, or risk management.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data collectiondata validationprocess improvementaudit readinesscompliance workflowsdocumentation preparationrisk assessment
Soft skills
organizational skillsattention to detailwritten communicationverbal communicationdiscretion