Job Description

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

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