Prepare global regulatory submissions (such as 510(k), PMA, MDR Technical Files, Annual Reports, etc.) for the orthopedic reconstruction device product portfolio. This includes submissions, notifications, etc. for new devices, modified devices and any other changes requiring submission, registration updates, etc. Support business critical sustaining activities for the legacy orthopedic product portfolio, including regulatory impact assessments and associated re-registrations for manufacturing transfers, processing changes, and design modifications. Work closely with project teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company's product launch timelines in all identified markets. Communicate with FDA and other regulatory bodies regarding submissions. Support cross-functional projects through the provision of regulatory submission/compliance strategy document, regulatory inputs, and documentation reviews (CER, IOVV, Risk Management Documentation, etc.) Support technical file and quality audits. Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements. Review and approve change requests for design, manufacturing and labelling changes to ensure compliance with FDA and international government regulations. Complete associated regulatory impact assessments and execute applicable re-registrations and change notifications. Review package inserts (IFU's), Surgical Techniques and promotional materials to ensure compliance with regulations. Support International Registrations for the Ortho product portfolio for all regions. Maintain, update, organize, etc. the existing regulatory files, as directed by management. Education: Bachelor’s or Master’s degree in Regulatory Affairs or closely related field. Will also consider applicants with BA or BS in Business Administration, Life Science, nursing, medical technology or related field with 3 or more years of prior work experience in the regulated medical industry. Experience: Minimum of 2 years of relevant regulatory experience in the medical device industry is required. Knowledge of current US and EU regulations is essential. Orthopedic device experience desired. Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology and complex documents. Ability to respond to inquiries from regulatory agencies. Ability to write detailed technical regulatory submissions, reports and business correspondence. Ability to effectively present information to other employees, management and regulatory agencies. Ability to use Microsoft Outlook, TEAMs, Word, Excel, PowerPoint. Travel Requirements: 0-5%.
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