Accountabilities & Responsibilities
• Develop and execute regulatory strategies for new and existing products, aligning regulatory pathways with business objectives.
• Influence product development, portfolio planning, and lifecycle management decisions by identifying regulatory risks, opportunities, and early tradeoffs.
• Lead the preparation and technical review of regulatory submissions, including 510(k)s, q-submissions, and other global filings, as appropriate.
• Determine submission requirements and provide recommendations to ensure alignment across Engineering, Clinical, Quality, and Manufacturing.
• Ensure accurate, timely maintenance of UDI/GUDID data, licenses, registrations, listings, and post approval commitments.
• Lead the development, interpretation, and continuous improvement of regulatory policies, procedures, and SOPs, in alignment with Regulatory management and applicable document-control processes.
• Monitor, assess, and communicate regulatory changes, translating requirements into actionable guidance for stakeholders.
• Partner with Quality and Operations to support audits, inspections, recalls, and remediation activities, ensuring effective regulatory risk management.
• Provide regulatory review and technical guidance for labeling, promotional materials, and advertising to support compliance with applicable regulations.
• Act as a strategic regulatory partner to R&D, Quality, Clinical, Manufacturing, Marketing, and Supply Chain teams.
• Mentor and coach regulatory team members and cross-functional partners, strengthening overall regulatory capability within the organization.
• Deliver training and education on regulatory requirements, trends, and best practices to promote an enterprise-wide compliance culture.
• Collaborate with external consultants, notified bodies, and legal counsel to resolve complex regulatory challenges.
• Ensure timely execution and completion of regulatory activities to support product launch timelines and business milestones.
• Maintain accurate, compliant regulatory documentation and systems.
• Uphold the highest ethical standards, confidentiality, and integrity in all regulatory interactions.
• Perform other duties as required to support the regulatory function and business objectives.