• Support the management and integration of quality management and improvement programs, compliance with regulatory environment and company practices
• Responsible for the coordination and completion of all government, regulatory, and documents for all business units in an organization
• Provide guidance assistance and technical support for the implementation of programs and practices
• Work with business units to establish or change procedures and to assure compliance
• Maintain documentation of compliance activities, such as complaints received or investigation outcomes
• Files appropriate reports with regulatory agencies
• Assists in the internal investigation of compliance issues
• Identifies issues that require follow-up or investigation
• Disseminates written policies and procedures related to compliance activities
• Participates in compliance audits; reviews regulatory agency reports and participates in formulating responses and corrective actions
• Assists in employee training on compliance related topics, policies, or procedures
• Verifies that all firm and regulatory policies and procedures have been documented, implemented, and communicated
• Keeps informed regarding pending industry changes, trends, and best practices and assess the potential impact of these changes on organizational processes
• Monitors compliance systems to ensure their effectiveness.
• Assists in the preparation of management reports regarding compliance operations and progress
• Provides assistance to internal or external auditors in compliance reviews
• Designs or implements improvements in communication, monitoring, or enforcement of compliance standards
• Assesses product, compliance, or operational risks and assists in the development of risk management strategies
• Assists in the oversight of internal reporting systems such as corporate hotlines and inform employees about these systems.
• Reviews communications such as product sales advertising to ensure there are no violations of standards or regulations
• Evaluates testing procedures to meet the specifications of environmental monitoring programs
• Reviews policies or operating guidelines for compliance with changes to environmental standards or regulation
• 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, prepare, or review regulatory submissions for domestic or international projects.
• 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 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