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.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Prepare or maintain technical files as necessary to obtain and sustain product approval.
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
Coordinate recall or market withdrawal activities as necessary.
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
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.
Identify relevant guidance documents, international standards, or consensus standards.
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
Review clinical protocols to ensure collection of data needed for regulatory submissions.
Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
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.
Participate in internal or external audits.
Compile and maintain regulatory documentation databases or systems.
Write or update standard operating procedures, work instructions, or policies.
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
Develop or track quality metrics.
Develop or conduct employee regulatory training.
Recommend adjudication of product complaints.
Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
Judgment and Decision Making.
Complex Problem Solving.
Management of Personnel Resources.
Bachelor degree in Psychology education, Economics education, Political Economy, Business Administration, Criminal Justice, Law Enforcement Administration, Sociology, Anthropology, International Relations and Affairs.