This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail.
Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation.
Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications.
Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc.
Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications" (U.S.) for changes that do not require a 510(k) submission.
Prepare/update technical files for CE marking with appropriate input from various functions (R&D, Quality, Medical, Manufacturing, etc.).
Submit notifications to the EU Notified Body for significant changes to CE marked products.
Maintain Regulatory documentation.
Support special projects, as needed.
Bachelor's degree (Engineering, Biology, or Regulatory Science) and a minimum of 3+ year(s) related experience; or equivalent combination of education and experience.
Proven experience with software as a medical device (SaMD) and mobile health app regulations.
In-depth knowledge of FDA guidance on digital health, cybersecurity, and mobile medical apps.
Track record of 510(k)/De Novo submissions for connected orthopedic or wearable devices.
Familiarity with IEC 62304, ISO 13485, and FDA Part 11 compliance for software validation.
Experience with EU MDR requirements for software and app-based devices (Annex I & XIII).
Effective collaboration with software, clinical, and human factors teams.
Post-market compliance expertise, including UDI, vigilance, and software change reporting.
Strong understanding of cybersecurity requirements and guidance (e.g., FDA, IMDRF).
Knowledge of US and/or international regulatory requirements (FDA, TGA, EU MDD, MDR, Health Canada, etc.).
Direct experience with regulatory submissions for Artificial Intelligence, Software as a Medical Device and Machine Learning (SaMD/ML) products.
Excellent attention to detail and proven organizational skills, able to prioritize and multi-task and see projects/assignments to completion.
Proficiency in Excel, Word, PowerPoint, Outlook and customer database management systems.
Proven leadership and negotiation skills, works well with all levels, able to successfully manage cross-departmental expectations.
Excellent written and verbal communication skills.
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