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Regulatory Affairs Specialist

Our client is currently seeking a Regulatory Affairs Specialist. Education: BA/BS in Science, Engineering, Legal, or Regulatory, Advanced degree and/or RAC(s) preferred. Experience: 3+ years of experience within medical device or other regulated industry. Knowledge of FDA Quality System Regulations (21 CFR), EU Medical Device Directives (MDD)and applicable guidance documents. Familiarity with EU Medical Device Regulation (MDR) and additional international regulations preferred. 510(k), IDE, PMA, CE Technical File/Design Dossier preparation, review, and submission experience. Experience interacting directly with FDA and Notified Body reviewers/inspectors. Understanding of the FDA device listing and establishment registration process. Demonstrated abilities and skills in the following key areas: Analytical and writing skills Organizational and planning skills Advanced PC skills (MS Outlook, Word, PowerPoint, Excel) Interpersonal communication, collaborative team work, and negotiation skills Complying with constantly changing regulatory procedures; reprioritizing work effectively Identifying and correcting errors and inconsistencies (e.g. grammatical, contextual, etc.) Rapidly building product knowledge and understanding of highly technical and scientific regulatory activities. Additional Job Details: The Regulatory Affairs Specialist works with direct supervision to bring medical devices to market and ensure ongoing compliance while continuing to develop their regulatory skills. Participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing materials, and evaluate proposed device changes. General Responsibilities: Work with minimum supervision, conferring with more senior staff when indicated. Keep supervisor regularly apprised of project status. Collaborate with New Product Development Teams to ensure US, EU and other international regulatory requirements are incorporated as part of the development process. Evaluate medical device regulations and develop strategies for bringing products to market. Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval to bring new or modified products to market. Partner with global regulatory affiliates and leverage Reconstructive product expertise to provide submission documentation for expedited international market access and sustaining support. Assess global impact of changes to launched products and support notifications/submissions as required. Review labeling and marketing literature for compliance with regulatory requirements. Additional tasks may include: Determining and communicating submission and approval requirements Compiling, preparing, reviewing and submitting regulatory dossiers to authorities Interfacing and coordinating directly with FDA, Notified Body reviewers, and other regulatory agencies on submissions, approvals or other issues. Reviewing and approving change documentation for regulatory impact on launched products. Providing regulatory input for and appropriate follow-up to inspections and audits. Reviewing and approving labeling, advertising and promotional items for compliance before release. Assisting in the development, implementation, and maintenance of regulatory procedures to ensure ongoing compliance of new and existing products. Preparing and updating US product registrations and listings. Providing regulatory input in CAPAs/NCs. Assisting in the establishment and maintenance of regulatory information systems both electronically and hard copy. Participating in process improvement activities and projects. Assisting in complex projects and performing delegated tasks as required. Ensuring compliance with product post-market or clearance requirements (progress reports, annual reports etc.). Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements. Identifying issues early in the submission preparation process that could impact product launch. Communicating and negotiating with regulatory authorities and stakeholders under supervision of more experienced RA team-members. Ensuring project team(s) and RA management remain informed regarding all regulatory agency/Notified Body correspondence. ID: 579466 Type: Contract Salary: Open

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