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. / Coordinate efforts associated with the preparation of regulatory documents or submissions.
Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
Recommend changes to company procedures in response to changes in regulations or standards.
Prepare or maintain technical files as necessary to obtain and sustain product approval.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Compile and maintain regulatory documentation databases or systems.
Participate in internal or external audits.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Escort government inspectors during inspections and provide post-inspection follow-up information as requested.