Regulatory Affairs Specialists

• Compile and maintain regulatory documentation databases or systems.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
• Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
• Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Participate in internal or external audits.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
• Coordinate recall or market withdrawal activities as necessary.
• Write or update standard operating procedures, work instructions, or policies.
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Recommend changes to company procedures in response to changes in regulations or standards.
• Identify relevant guidance documents, international standards, or consensus standards.
• Review clinical protocols to ensure collection of data needed for regulatory submissions.
• 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.
• Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

No durable tasks identified for this role — its real, individually-assessed tasks consistently read as augmentable (65%).