US Regulatory Affairs Specialist

Henry Schein•Melville, SC

8d•Onsite

About The Position

Responsible for ensuring company operations remain compliant with all federal, state, and international regulations governing controlled substances and regulated products. This role oversees licensing, reporting, recordkeeping, audits, and internal compliance processes related to DEA and other regulatory agency requirements. The position partners cross-functionally with quality, operations, supply chain, legal, and commercial teams to support compliant business practices while minimizing regulatory risk.

Requirements

Understanding of regulations applicable to HS operations.
General proficiency with tools, systems, and procedures
Basic planning/organizational skills and techniques
Basic analysis and problem solving skills
Basic verbal and written communication skills
Typically 1 to 3 years of related professional experience.

Responsibilities

Research and analyze applicable laws and regulations; develop and implement the necessary policies and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements.
Implement systems and processes needed to ensure compliance with the receipt, storage and distribution of controlled substances, list 1 chemicals and other regulated products; as well as tracking distribution of prescription drugs and medical devices.
Conduct periodic audits on facilities and customer site visits to assess levels of compliance and risk.
Monitor compliance with DOT requirements for the classification, storage and distribution of Hazardous Materials; as well as the activities to comply with environmental laws, including the registration and disposal of pesticides and other type of type of chemical products.
Coordinate the implementation of systems and procedures to ensure compliance with OSHA regulations.
Support Distribution Center management and designated staff on the actions necessary to maintain regulatory compliance.
Provide support during government inspections and formulating the appropriate response and corrective actions.
Provide guidance to the company and subsidiaries to perform actions in order to maintain regulatory compliance for various facilities.
Provide support to Corporate Brand Development Group and other Business Units researching issues pertaining to regulatory matters.
Secure and maintain proper company licensure and product registration as needed to supports HSI Operations and Business Units.
Provide support in the coordination and conducting routine Regulatory audits of Henry Schein facilities, affiliates and subsidiaries.
Develop appropriate awareness and training programs for TSMs consistent with regulatory compliance policies and procedures.
Conduct routine Regulatory audits of Henry Schein facilities, affiliates and subsidiaries.
Participate in special projects and performs other duties as required.