Regulatory Compliance Specialist

Regulatory Compliance Specialist
In Tempe, Arizona 85281

Job Description

Workway is a professional staffing firm, working with organizations across the country to place exceptional candidates. We are looking for a Regulatory Compliance Specialist responsible for the specific duties which will include:

  • Communicating with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance requirements, or clarification and follow-up of submissions under review.
  • Scheduling with and escort state inspectors during inspections and provide post-inspection follow-up information as requested.
  • Analyzing regulatory deficiencies or complaints and make recommendations regarding their correcting Coordinate, prepare, or review regulatory submissions for state-specific licensing entities in states where the company operates.
  • Interpreting regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures, including communication with General Counsel and Assistant General Counsel.
  • Assisting with technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Assisting with review of product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Advising project teams on subjects such as pre-market/pre-inspection/pre-license regulatory requirements, export and labeling requirements, or other regulatory compliance issues.
  • Compiling and maintaining regulatory documentation databases or systems.
  • Coordinating efforts associated with the preparation of regulatory documents or submissions.
  • Determining the types of regulatory submissions or internal documentation that are required in situations such as proposed changes in collaboration with the Legal Department.
  • Maintaining current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Obtaining and distribute updated information regarding regulations, laws, guidelines, or standards.
  • Preparing or assist with the preparation of additional information or responses as requested by regulatory agencies. 
  • Preparing or maintain technical files as necessary to obtain and sustain license approval.
  • Recommending changes to company procedures in response to changes in regulations or standards.
  • Review and revise protocols to ensure collection of data needed for regulatory submissions.
  • Writing or update standard operating procedures, work instructions, or policies.
  • Researching and fulfill various legal administrative duties as assigned.
  • Participating in ongoing education and professional development opportunities.
  • Working collectively and respectfully with other team members.]

Specific qualifications for the position include

  • 3+ years of experience as a Regulatory Compliance Specialist providing research, familiarity with state regulatory entities and regulatory compliance support is required. 
  • High School diploma or GED required

Let one of our recruiters assist you in finding and preparing for interviews with our clients. Whether you are interested in a direct hire, temp-to-hire, or temporary position, Workway can help you to put your best foot forward. Contact us today! 
 

 

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