US Sr Regulatory Affairs Specialist

Henry Schein Melville , NY 11747

Posted 2 weeks ago

JOB OVERVIEW:

This position isresponsible for researching and analyzing applicable legislation and Federal,State and Local regulations to ensure the company's general DEA ongoingcompliance. Provide guidance to Operations and other areas of the company oncompliance issues with relation to area of expertise. Propose, Develop,and Lead the implementation of Regulatory strategies of various complexitieswith small to large cross-functional teams

KEY RESPONSIBILITIES:

Typically responsiblefor two or more of the following duties:

  • Researches and creates comprehensive analysis summaryof applicable laws and regulations; then develops and implements thenecessary systems, policies, and procedures to ensure the Company'songoing compliance with Federal, State and local requirements with specialemphasis on DEA and State Regulatory requirements related to controlledsubstances distribution and List 1 chemicals using formalized projectmanagement techniques.

  • Researchcustomer and customer orders of controlled substances and List 1 chemicalsfor compliance with DEA/ State regulations.

  • Creates, Develops, and

Conducts awareness and training programs for TSMs consistent with regulatorycompliance policies and procedures.

  • Provides support/guidance:

  • During government inspections and formulating theappropriate response and corrective actions.

  • To the company and subsidiaries to perform actions inorder to maintain regulatory compliance for their facilities.

  • To the Henry Schein's Brand products and other

Business Units researching issues pertaining to regulatory matters.

  • Secures and maintains:

  • Henry Schein company licensure and productregistration as needed to support HSI Operations and Business Units.

  • Supplier licensure information to ensure partners arein good standing.

  • Conducts internal investigations/analysis of businesssystems/data to identify root cause and optimal effective solution.

  • Conducts Periodic Regulatory audits of Henry Scheinfacilities, affiliates and subsidiaries to assess levels of compliance andrisk.

  • Conduct periodic audits on supplier facilities andcustomer site visits to assess levels of compliance and risk.

  • Participate in special projects and performs otherduties as required.

WORK EXPERIENCE:

  • Typically 3 to 5 or more years ofincreasing responsibility in terms of any applicable professional experience.

  • Prior DEA, Legal, Law Enforcement, Pharmacy or Medical Experience a plus

PREFERREDEDUCATION:

Bachelor's Degree orglobal equivalent in related discipline.

GENERALSKILLS & COMPETENCIES:

  • Professional skills with an understanding of DEA and State Regulations relative to the storage, distribution, record keeping, and monitoring of controlled substances and their regulated products.

  • General proficiency with MS Office tools.

  • Strong ability to work within a team environment

  • Strong planning/ organizational skills and techniques.

  • Strong analysis and problem solving skills.

  • Excellent 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.

  • Knowledge and understanding of regulations and guidance governing healthcare distribution.

  • Medical Device and Pharmaceutical Regulatory Regulations

  • DEA and State Regulations

  • Strong understanding of distribution and auditing processes.

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate againstapplicants or employees on the basis of race, color, religion, creed, nationalorigin, ancestry, disability that can be reasonably accommodated without unduehardship, sex, sexual orientation, gender identity, age, citizenship, maritalor veteran status, or any other legally protected status.

For more informationabout career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers.


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US Sr Regulatory Affairs Specialist

Henry Schein