Regulatory Affairs Specialist-Medical Device (Cary)

Position Description (Principle Duties and Responsibilities)

• Analyzing links between global, societal, and economic trends; stakeholder concerns and regulatory issues; and the implications for regulatory strategy.
• Remediating regulatory documentation in accordance with relevant regulatory requirements for US 510(k) submissions.
• Remediating EU MDR Technical Documentation Files in accordance with regulatory standards for Class IIa medical devices.
• Developing and updating global, regional, and multi-country regulatory strategies, and aligning them with organizational goals.
• Providing guidance to integrate regulatory considerations into global product entry and exit strategies.
• Assessing all requirements and potential obstacles for market access and distribution (federal, provincial / territorial / state, reimbursement, purchasing groups) and developing solutions to address anticipated barriers.
• Critically evaluating the impact of changing regulations on preapproval and post-approval strategies and approaches.
• Negotiating with regulatory authorities on complex issues throughout the product lifecycle.
• Establishing working relationships and interfaces with multiple government and non-government organizations affecting market access and distribution.
• Identifying the need for and managing the development and execution of new regulatory procedures and standard operating procedures.
• Developing and managing programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
• Evaluating risks related to product and clinical safety issues during clinical phases and recommending appropriate regulatory solutions.
• Evaluating proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposing plans for modifications that do not require submissions.
• Reviewing and assessing proposals submitted to regulatory authorities regarding regulatory paths and clinical plans.
• Providing regulatory guidance on strategies for proposed product claims and labeling.
• Ensuring clinical and nonclinical data align with regulatory requirements and support the proposed product claims.
• Preparing cross-functional teams for interactions with regulatory authorities, including panels and advisory committees.

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