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Santa Clarita, United States BioTalent Full time

*Hybrid on-site role in Valencia, CA - at least 1 day per week The Regulatory Affairs Specialist is responsible for supporting regulatory activities which lead to, and maintain, regulatory compliance and approval for products globally. Duties and Responsibilities Perform gap analyses between new/revised regulations and standards and the Quality Management System (QMS). Review and assess published literature, preclinical data, clinical investigation results, field performance data and other relevant post-market surveillance data in order to evaluate device safety and performance. Compile Clinical Evaluation Plans and Reports. Assess reportability of changes to: labeling, design, materials, manufacturing process, sterilization or packaging. Working with other departments, gather data for completing Post-Market Surveillance Reports, Periodic Safety Update Reports, Critical Analysis Reports, Summary of Safety and Performance Reports, etc. Compile needed post-market reports. Facilitate the completion of actions identified as a result of post-market reports. Compile necessary documentation for the creation of technical files. Maintain technical files. Assist with writing submission documents for regulatory agencies (FDA, Health Canada, etc.) and Notified Bodies. Develop responses to questions or deficiency letters from regulatory agencies and notified bodies. Use technical/clinical writing skills to clearly describe technical information for third-party reviewers. Perform submissions using the regulatory agency’s electronic submission process, if applicable (ESG, EUDAMED, etc.). Maintain registrations, certifications, and/or licenses, as applicable. Assist new product development teams to provide regulatory support to the project. Develop positive working relationships with other departments. Actively participate in third-party audits. Qualifications Medical Device experience (doesn’t need to be ortho, but have taken a device from feasibility through market and post-market), design control for at least 1 product line, US/EU MDR, International is a nice to have. EU Experience: drafting technical files, corresponding with notified bodies, answering Q&A. US Experience: 510ks, LTFs, interacting with FDA, resolving additional questions. Hands-on contribution to authorship of 510(k) submissions. #J-18808-Ljbffr