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GEMCORE · 20 hours ago

Regulatory Compliance Analyst

Hudson, Ohio, United States

Full-time

Onsite

New Grad, Entry Level

0+ years exp

GEMCORE is a well-established healthcare distribution company recognized for its growth and workplace culture. They are seeking a Compliance Analyst to assist in the administration of their Corporate Compliance Program, ensuring adherence to regulatory requirements for their pharmacy operations.

Health CareMedicalPharmaceutical

Responsibilities

Research federal and state regulatory requirements for the distribution of medical devices

Process state and federal license applications to ensure medical device license requirements compliance

Assists in the implementation and monitoring of compliance controls, compliance procedures and operational processes

Conducts timely filings of reporting and renewal activity with licensing and regulatory agencies for Wholesale Distributor, DME and Pharmacy

Maintain database and create electronic records of company contracts, licenses and agreements

Inquires and responds to designated regulatory and accreditation agencies

Maintains working knowledge of basic healthcare compliance legal and regulatory requirements

Research regulatory changes that impact standard operating procedures and standards

Be knowledgeable of the agencies, such as the state Pharmacy Boards, Departments of Health, Secretary of State offices, Drug Enforcement Agency (DEA), Food and Drug Administration (FDA), and USPTO, that issue the licenses and credentials maintained by the company

Qualification

Regulatory compliance knowledgeHealthcare compliance experienceProcess improvement knowledgeComputer skillsAttention to detailOrganizational skillsWritten communicationVerbal communicationTime management