US Regulatory Affairs Specialist at Henry Schein in Remote

Summary: Henry Schein, Inc. is a company focused on compliance with federal, state, and international regulations governing controlled substances and regulated products. The US Regulatory Affairs Specialist is responsible for ensuring company operations remain compliant, overseeing licensing, reporting, audits, and internal compliance processes related to DEA and other regulatory agency requirements. 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 Required Qualifications: - Responsible for ensuring company operations remain compliant with all federal, state, and international regulations governing controlled substances and regulated products - Oversees licensing, reporting, recordkeeping, audits, and internal compliance processes related to DEA and other regulatory agency requirements - Partners cross-functionally with quality, operations, supply chain, legal, and commercial teams to support compliant business practices while minimizing regulatory risk - 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 - 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 Preferred Qualifications: - Typically a Bachelor's Degree or global equivalent in related discipline Required Skills: Regulatory compliance, DEA regulations, Controlled substances regulations, Hazardous Materials regulations, OSHA regulations, Licensing and product registration, Regulatory audits Benefits: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program, Volunteer Opportunities