Specialist, Regulatory Affairs

Coordinate, prepare, or review regulatory submissions for domestic or international projects.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• 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.