Regulatory Affairs Specialists

• 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 compliance 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.
• Analyze product complaints and make recommendations regarding their reportability.
• Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• Review clinical protocols to ensure collection of data needed for regulatory submissions.
• Compile and maintain regulatory documentation databases or systems.
• Recommend changes to company procedures in response to changes in regulations or standards.
• Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
• Write or update standard operating procedures, work instructions, or policies.
• Participate in internal or external audits.
• Develop or conduct employee regulatory training.
• Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.

Source: O*NET OnLine information for Regulatory Affairs Specialists.

• Writing - Communicating effectively in writing as appropriate for the needs of the audience.
• Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
• Speaking - Talking to others to convey information effectively.
• Complex Problem Solving - Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
• Judgment and Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one.
• Active Listening - Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
• Systems Analysis - Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
• Active Learning - Understanding the implications of new information for both current and future problem-solving and decision-making.
• Systems Evaluation - Identifying measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the system.

Source: O*NET OnLine information for Regulatory Affairs Specialists.