Principal Regulatory Affairs SpecialistComrise • Cary, IL, US
Principal Regulatory Affairs Specialist
Comrise • Cary, IL, US
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job_description.job_card.job_descriptionAssesses 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
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Regulatory Specialist • Cary, IL, US
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