Regulatory Affairs Specialist III

Responsibilities:With adequate supervision, the Regulatory Affairs Specialist III is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations.The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.Support the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices.Represent RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts.Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations.Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR.Support international geographies to gain and maintain product approvals.Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing.Requirements:Bachelor's degree or an equivalent combination of education and work experience3+ years of experience in Regulatory Affairs or related discipline in medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling)Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as US 30-day notices and annual reports and EU MDR technical documentation.Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint, and Adobe AcrobatTeam player with excellent interpersonal skills#J-18808-Ljbffr

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