Regulatory Compliance Specialist
In Tempe, Arizona 85281
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!