Principal Specialist, Regulatory Affairs
• Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
• Remediation of regulatory documentation in accordance with relevant regulatory requirements for US 510(k)
• Remediation of EU MDR Technical Documentation File in accordance with relevant regulatory requirements for Class IIa medical device
• Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
• Provides guidance to integrate regulatory considerations into global product entry and exit strategy
• Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
• Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
• Negotiates with regulatory authorities on complex issues throughout the product lifecycle
• Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
• Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
• Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
• Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
• Provides regulatory guidance on strategy for proposed product claims/labeling
• Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
• Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees