Compliance

• Develop and execute the regulatory strategy for new product development, design changes, and field safety corrections
• Author 510K submissions, pre-sub documents, EUMDR tech files, and contribute to international regulatory submissions
• Participate in strategic product development, design solutions from concept phase to product delivery phase
• Provide regulatory guidance throughout design and development
• Act as a Regulatory Subject Matter Expert (SME) and manage special projects across product lines
• Monitor global regulatory landscapes and guide cross-functional teams on regulation changes
• Communicate new changes and facilitate interpretation to ensure compliance
• Support product defect assessments, health hazard evaluations, corrections and removals as a regulatory SME
• Review labeling, marketing materials, and claims substantiation evidence

Principal Regulatory Affairs Specialist

Senior Regulatory Risk Specialist

Regulatory Engineer

Executive Director, Regulatory Science & Strategy – Oncology

Director, Global Regulatory Leader

Director, Global Regulatory Leader