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Sr Regulatory Affairs Specialist

Our client is currently seeking a Sr Regulatory Affairs Specialist. The Sr. 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. Additional Job Details: 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. Experience with additional international regulations preferred. 510(k), Letter-to-File, CE Technical File/Design Dossier preparation, review, and submission experience. 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 ID: 579473 Type: Contract Salary: Open

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