Sr. Regulatory Affairs Specialist
This position is responsible for researching and analyzing applicable legislation and Federal, State and Local regulations to ensure the company’s general DEA ongoing compliance. Provide guidance to Operations and other areas of the company on compliance issues with relation to area of expertise. Propose, Develop, and Lead the implementation of Regulatory strategies of various complexities with small to large cross-functional teams
Typically responsible for two or more of the following duties:
- Researches and creates comprehensive analysis summary of applicable laws and regulations; then develops and implements the necessary systems, policies, and procedures to ensure the Company’s ongoing compliance with Federal, State and local requirements with special emphasis on DEA and State Regulatory requirements related to controlled substances distribution and List 1 chemicals using formalized project management techniques.
- Research customer and customer orders of controlled substances and List 1 chemicals for compliance with DEA/ State regulations.
- Creates, Develops, and Conducts awareness and training programs for TSMs consistent with regulatory compliance policies and procedures.
- Provides support/guidance:
- During government inspections and formulating the appropriate response and corrective actions.
- To the company and subsidiaries to perform actions in order 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 product registration as needed to support HSI Operations and Business Units.
- Supplier licensure information to ensure partners are in good standing.
- Conducts internal investigations/analysis of business systems/data to identify root cause and optimal effective solution.
- Conducts Periodic Regulatory audits of Henry Schein facilities, affiliates and subsidiaries to assess levels of compliance and risk.
- Conduct periodic audits on supplier facilities and customer site visits to assess levels of compliance and risk.
- Participate in special projects and performs other duties as required.
- Typically 3 to 5 or more years of increasing responsibility in terms of any applicable professional experience.
- Prior DEA, Legal, Law Enforcement, Pharmacy or Medical Experience a plus
Bachelor’s Degree or global equivalent in related discipline.
GENERAL SKILLS & 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 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.
Interested applicants should click the link (https://henryschein.taleo.net/careersection/hsi1/jobdetail.ftl?job=R109651&lang=en&sns_id=mailto#.XKI8V0avSQI.mailto) to apply.
For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers.
Job posted: 2019-04-01