{"c":"13-1041.07","n":"Regulatory Affairs Specialists","d":"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.","g":"13","tasks":[{"t":"Coordinate efforts associated with the preparation of regulatory documents or submissions.","core":true,"id":18054,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.","core":true,"id":18045,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.","core":true,"id":18061,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Coordinate, prepare, or review regulatory submissions for domestic or international projects.","core":true,"id":18048,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Prepare or maintain technical files as necessary to obtain and sustain product approval.","core":true,"id":18062,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.","core":true,"id":18049,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.","core":true,"id":18055,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Coordinate recall or market withdrawal activities as necessary.","core":true,"id":18067,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.","core":true,"id":18052,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.","core":true,"id":18070,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.","core":true,"id":18051,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Identify relevant guidance documents, international standards, or consensus standards.","core":true,"id":21094,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.","core":true,"id":18050,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Review clinical protocols to ensure collection of data needed for regulatory submissions.","core":true,"id":18065,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.","core":true,"id":21095,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.","core":true,"id":18058,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Recommend changes to company procedures in response to changes in regulations or standards.","core":true,"id":18063,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Participate in internal or external audits.","core":true,"id":18060,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Compile and maintain regulatory documentation databases or systems.","core":true,"id":18053,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Write or update standard operating procedures, work instructions, or policies.","core":true,"id":18066,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.","core":true,"id":18059,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Develop or track quality metrics.","core":true,"id":18068,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Develop or conduct employee regulatory training.","core":true,"id":18056,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Recommend adjudication of product complaints.","core":true,"id":21096,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.","core":false,"id":19553,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Direct the collection and preparation of laboratory samples as requested by regulatory agencies.","core":false,"id":18069,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.","core":false,"id":18064,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.","core":false,"id":19557,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.","core":false,"id":19552,"r":20,"dt":"08/2019","src":"Occupational Expert"},{"t":"Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.","core":false,"id":19554,"r":20,"dt":"08/2019","src":"Occupational Expert"}]}