Regulatory Affairs and Compliance Apprenticeships are designed to help employers make their regulatory submissions on time and ensure they remain in good standing with the Food and Drug Administration (FDA) . Our expertise covers food, pharma, biotech and medical device industries.
This program is designed to train for a career as a Regulatory Affairs Associate within the scientific products industry. This includes practical, on-site instruction at a host company in areas such as coordination and documentation of internal regulatory processes, such as internal audits, inspections, license renewals or registrations. May compile and prepare materials for submission to regulatory agencies. Complementary topics such as regulatory pathways and regulatory operations, regulatory submissions and review process, good documentation practices industry regulatory guidances and recognized industry certification.
This program is designed to train for a career as a Regulatory Compliance Associate within the scientific products industry. This includes practical, on-site instruction at a host company in areas such as management and integration of quality management and improvement programs, conformity with regulatory environment and company practices, guidance and technical support for the implementation of programs and practices to ensure compliance with ethical or Regulatory standards. Complementary topics such as regulatory pathways and operations, strategic planning for recalls, goods documentation practices, industry regulatory guidelines and recognized industry certification.
This 18-24 Month apprenticeship includes the goal of becoming an employee upon completion of program. If you are unable to directly hire the apprentice at the end they can be converted to a staffing arrangement or we can help them find a new position. Apprentices can be military veterans, students/recent graduates, mothers or fathers returning to the workforce or individuals coming off disability.
• 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
Employers interested in Regulatory Affairs and Compliance Apprenticeships should contact us using the form down below.
If you are interested in starting your career in one of our Regulatory Affairs and Compliance Apprenticeships then submit your resume on our page for Prospective Apprentices.
Interested in working with us? Reach out below.