Compliance

• Prepare and review global regulatory submissions including US 510(k), US Class III Annual Reports, US PMA/HDE Supplements and EU MDR technical documentation
• Support regional regulatory colleagues in preparation of international regulatory submissions for new and modified devices
• Serve as RA lead on project teams to develop regulatory strategies, testing requirements and documentation to meet product launch timelines
• Manage/lead regulatory-driven projects and execute global regulatory strategies for product release and market expansion
• Maintain knowledge of global regulations, standards, guidance documents, country-specific requirements, internal procedures, medical devices and medical terminology
• Maintain computer databases for cleared/approved product release, UDI database accuracy, and submission tracking/metrics
• Plan, lead and support internal and Regulatory agency audits and engagement with regulatory authorities
• Lead regulatory assessments for engineering change requests and manage updates to registrations
• Develop and maintain company global and local SOPs to assure regulatory compliance
• Provide technical guidance and regulatory training/mentoring to Regulatory Affairs employees and cross-functional teams
• Develop/review product labeling (IFUs, PICs, PILs), Surgical Techniques and promotional materials for regulatory compliance

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