Regulatory Affairs Specialist II
Job Description: * Compile and maintain regulatory documentation databases or systems. * Coordinate efforts associated with the preparation of regulatory documents or submissions. * Analyze product complaints and make recommendations regarding their reportability. * Develop or conduct employee regulatory training. * Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. * Escort government inspectors during inspections and provide post-inspection follow-up information as requested. * Coordinate, prepare, or review regulatory submissions for domestic or international projects. * Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. * 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. * Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. * Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. * Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance. * Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. * Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards. * Participate in internal or external audits. * Prepare or direct the preparation of additional information or responses as requested by regulatory agencies. * Prepare or maintain technical files as necessary to obtain and sustain product approval. * Recommend changes to company procedures in response to changes in regulations or standards. * Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. * Review clinical protocols to ensure collection of data needed for regulatory submissions. * Write or update standard operating procedures, work instructions, or policies. * Coordinate recall or market withdrawal activities as necessary. * Develop or track quality metrics. * Direct the collection and preparation of laboratory samples as requested by regulatory agencies. * Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines. * Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste. * Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste. * Monitor national or international legislation on ozone-depleting substances or global warming. * Obtain clearances for the use of recycled plastics in product packaging. * Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances. * Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.Must haves:Bachelors degree3-5 years of Work ExperienceKnowledge of US, EU and Canada Medical Device RegulationsFamiliarity with PLM WindChill and Veeva RIM platforms (not a mandatory requirement)Comments for Suppliers: