Regulatory Affairs Specialists

Code: 13-1041.07

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.

Tasks:

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.