Regulatory Affairs Specialist

Job TitleResponsible for assisting the team with regulatory filings as necessary to market Client products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.DutiesAssist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions.Respond to requests from foreign government and/or distributors as neededAssist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified productsProvides regulatory direction to development project teams as a core team member; develops regulatory strategy for new productsEvaluate risk of proposed regulatory strategies; may offer solutionsReviews proposed labeling for compliance with applicable global regulationsWrites and manages the development of package insertsReviews and evaluations promotion and advertising material for compliance with applicable regulationsReviews proposed product changes for impact on regulatory status of the productCommunicates with regulatory and governmental agencies with supervisionApplies FDA regulations to business practices and provides regulatory input, advice and guidance to design teamsSkillsStrong writing, communication, and interpersonal skillsStrong attention to detail; ability to multi-task and balance competing prioritiesKnowledge of overall business environment, the orthopaedic industry, and the marketplaceAbility to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional areaAbility to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levelsKnowledge of FDA, EU, and other regulatory body regulationsAbility to identify risk in Regulatory strategiesStrong problem solving skillsEffective negotiating skillsBasic computer skills, including Microsoft Office SuiteEducationBachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferredA minimum of one year of experience in orthopaedic or medical device industry preferredA minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field requiredRegulatory Affairs Certification (US or EU) preferredA combination of education and experience may be considered