Regulatory Affairs Specialists

<ul><li>Coordinate efforts associated with the preparation of regulatory documents or submissions.</li><li>Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.</li><li>Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.</li><li>Coordinate, prepare, or review regulatory submissions for domestic or international projects.</li><li>Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.</li><li>Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.</li><li>Prepare or maintain technical files as necessary to obtain and sustain product approval.</li><li>Coordinate recall or market withdrawal activities as necessary.</li><li>Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.</li><li>Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.</li><li>Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.</li><li>Identify relevant guidance documents, international standards, or consensus standards.</li><li>Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.</li><li>Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.</li><li>Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.</li><li>Review clinical protocols to ensure collection of data needed for regulatory submissions.</li><li>Recommend changes to company procedures in response to changes in regulations or standards.</li><li>Compile and maintain regulatory documentation databases or systems.</li><li>Participate in internal or external audits.</li><li>Write or update standard operating procedures, work instructions, or policies.</li><li>Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.</li><li>Develop or track quality metrics.</li><li>Develop or conduct employee regulatory training.</li><li>Recommend adjudication of product complaints.</li></ul>