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Regulatory Affairs Associate at Henry Schein

Posted in Compliance 30+ days ago.

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Type: Full Time
Location: Melville, New York

Job Description:


This position is responsible to assist acquiring, maintaining, and auditing company licensing and product registration. Research and analyze applicable legislation and Federal, State and Local regulations to ensure the companys ongoing compliance. Assist with contacting Federal, State, and local government agencies (i.e., FDA, DEA, EPA, DOT, FAA, and State Pharmacy Boards) to obtain information related to regulatory compliance issues.



* Assist with the research of applicable Federal, State and local regulations and with the development and implementation of the necessary policies and procedures to ensure the companys ongoing compliance with current and new requirements.

* Assist with the processes and procedures needed to ensure compliance with the receipt, storage and distribution of controlled substances, list 1 chemicals and other regulated products.

* Provide assistance monitoring compliance with DOT requirements for the classification, storage and distribution of Hazardous Materials.

* Assist with the activities to ensure ongoing compliance with Federal and State environmental laws, including the registration and disposal of pesticides and other type of chemical products.

* Assist to coordinate the implementation of systems and procedures to ensure compliance with OSHA regulations.

* Participate in routine Regulatory audits of Henry Schein facilities, affiliates and subsidiaries.

* Assist with development of training programs for distribution center staff consistent with regulatory compliance policies and procedures.

* Support the implementation of 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.

* Maintain an accessible database of all current state licenses.

* Support accreditation surveys (i.e., NABP/VAWD) in a timely fashion so as to allow for uninterrupted compliance.

* Provide support to secure and maintain proper company licensure and product registration as needed to supports HSI Operations and Business Units.


Typically 1 or more years of related experience.


General education, vocational training and/or on-the-job training. Bachelors degree preferred.


* Excellent time management skills and the ability to prioritize work

* Attention to detail and accuracy

* Customer service oriented

* Interpersonal communication skills

* Plan and arranges activities

* Good written and verbal communication skills

* Ability to maintain confidential information

* Ability to work in a team environment

* Ability to multi-task

* Capacity to work under pressure

* Proficient in MS Office


* General understanding of regulations applicable to HS operations

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.

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