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Occupation information for

Regulatory Affairs Specialists
District Of Columbia

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description

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

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details

Currently Employed: 3,060

Projected Annual Job Openings: 60

Typical Hourly Wage: $31.22 - $48.51

Typical Annual Salary: $64,900 - $100,900

See Job Listings (3)
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typical training

Typical education needed for entry: Bachelor's degree

Typical work experience needed for a job in this occupation: None

Typical on-the-job training once you have a job in this occupation: Moderate-term on-the-job training

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typical job duties

  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

tools & technology


Tools:
  • Desktop computers
  • Notebook computers
  • Personal computers
  • Scanners
  • Special purpose telephones

Technology:
  • Analytical or scientific software
  • Data base user interface and query software
  • Document management software
  • Office suite software
  • Project management software

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