Coordinates and documents internal regulatory processes, such as internal audits, inspections, license renewals or registrations. May compile and prepare materials for submission to regulatory agencies.
This career is part of the Government and Public Administration cluster Governance pathway.
A person in this career:
- Coordinates, prepares, or reviews regulatory submissions for domestic or international projects.
- Provides technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Reviews product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Interprets regulatory rules or rule changes and ensures that they are communicated through corporate policies and procedures.
- Advises project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Determines the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Prepares or maintains technical files as necessary to obtain and sustain product approval.
- Coordinates efforts associated with the preparation of regulatory documents or submissions.
- Prepares or directs the preparation of additional information or responses as requested by regulatory agencies.
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