Sr. Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist for top rated medical products company


Must possess specialized knowledge in one of the following areas:


Safety, Environmental or OHSA regulations



JOB OVERVIEW:


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 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 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 the company's Operations and Business Units.
Conduct routine Regulatory audits of facilities, affiliates and subsidiaries.
Develop appropriate awareness and training programs for TSMs consistent with regulatory compliance policies and procedures.Conduct routine Regulatory audits of the company's facilities, affiliates and subsidiaries.
Participate in special projects and performs other duties as required.






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 on a specific Regulatory area.
Strong understanding of manufacturing, distribution and auditing processes.
General knowledge of ISO 9000.



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 related discipline. Typically holds 1 or more industry certifications.

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Reference number US_EN_2_022924_141058