This position is responsible to acquire/maintain/audit company licensing and product registration. Research and analyze applicable legislation and Federal, State, and Local regulations to ensure the company’s ongoing compliance. Provide guidance to Operations and other areas of the company on compliance issues with relation to the area of expertise.
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 types 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.
Conduct 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.
WORK EXPERIENCE: Typically 3 to 5 or more years of increasing responsibility in terms of any applicable professional experience.
PREFERRED EDUCATION: Bachelor's Degree or global equivalent in a related discipline. Typically holds 1 or more industry certifications.
GENERAL SKILLS & COMPETENCIES:
Professional skills with an understanding of industry practices and company policies and procedures.
General proficiency with tools, systems, and procedures.
Good planning/ organizational skills and techniques.
Good analysis and problem-solving skills.
Good writing and communication skills.
Excellent conflict resolution skills. Self -starter in creating issue resolution
Excellent decision-making skills.
Excellent interpersonal skills.
Exercise judgment within defined procedures and practices to determine appropriate action.
Direction from manager/director is needed on some complex issues.
Developing professional credibility.
SPECIFIC KNOWLEDGE & SKILLS:
Thorough understanding of regulations applicable to HS operations.
Specialized knowledge in a specific Regulatory area.
Strong understanding of manufacturing, distribution and auditing processes.
General knowledge of ISO 9000.
Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
Henry Schein, Inc. (Nasdaq: HSIC) is a solutions company for health care professionals powered by a network of people and technology. With more than 22,000 Team Schein Members serving more than 1 million customers globally, the Company is the world's largest provider of Business, Clinical, Technology and Supply Chain solutions to enhance the efficiency of office-based dental, animal health, and medical practitioners. The Company also serves dental laboratories, government and institutional health care clinics, and other alternate care sites.
A Fortune 500® Company and a member of the S&P 500® and the Nasdaq 100® indexes, Henry Schein's network of trusted advisors provides health care professionals with the valued solutions they need to improve operational success and clinical outcomes. The Company offers customers exclusive, innovative products and solutions, including practice management software, e-commerce solutions, specialty and surgical products, as well as a broad range of financial services. Henry Schein operates through a centralized and automated distribution network, with a selection of more than 120,000 branded products and Henry Schein private-brand products in stoc...k, as well as more than 180,000 additional products available as special-order items.
Headquartered in Melville, N.Y., Henry Schein has operations or affiliates in 34 countries. The Company's sales reached a record $12.5 billion in 2017, and have grown at a compound annual rate of approximately 15 percent since Henry Schein became a public company in 1995. For more information, visit Henry Schein at www.henryschein.com, Facebook.com/HenrySchein, and @HenrySchein on Twitter.
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