Sr. Regulatory Affairs SME - Medical Devices & Diagnostics

Tunnell Government Services•Bethesda, MD

1d•Onsite

About The Position

Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us. Serve as the regulatory subject matter expert (SME) for medical devices and in vitro diagnostics (IVDs) on project coordination teams (PCTs) across various BARDA programs. Provide expert consultation on regulatory strategy development to ensure alignment with FDA requirements and evolving FDA guidance.

Requirements

Must be a US Citizen or a full Green Card holder.

Responsibilities

Attend regularly scheduled project coordination team meetings to monitor progress of projects
Review contract statement of works to ensure regulatory milestones and deliverables are appropriate, clearly outlined, and consistent with applicable regulations and guidance
Review and provide comments on overall regulatory strategy to ensure completion of regulatory deliverables in the contract is attainable. Provide recommendations on adjustment of regulatory strategy as needed throughout the contract lifecycle
Answer regulatory questions as needed
Proactively identify regulatory risks that may interfere with completion of regulatory deliverables and identify solutions
Review and provide critical feedback on regulatory submissions and supporting documentation, including Pre-Submissions, IDEs, 510(k)s, De Novos, PMAs, and EUA packages, ensuring completeness, scientific validity, and regulatory compliance.
Review and interpret FDA feedback received. As appropriate, provide an assessment of next steps, potential risks, and probable changes to regulatory strategy in order to meet contractual milestones and deliverables
Attend FDA submission meetings and interpret FDA feedback as appropriate
Identify regulatory risks and gaps in development programs and proactively recommend mitigation strategies
Review pre-award proposals for funding and provide consultation on the feasibility of the proposed regulatory plans
Participate in cross-divisional working groups as the regulatory subject matter expert
Track and interpret evolving regulatory policies, guidances, and enforcement trends related to diagnostics and devices, and translate these into actionable recommendations for BARDA leadership and partners.
Interface with FDA and other regulatory authorities as needed, supporting meeting preparation, briefing packages, and follow-up actions.
Contribute to RQA educational outreach initiatives by, for example, presenting in Lunch and Learn seminars and/or contributing to the dissemination of regulatory intelligence information.
Contribute to internal best practices development and the generation of regulatory templates to strengthen BARDA’s regulatory readiness and consistency across programs.
Work collaboratively with RQA Leadership and recommends regulatory courses of action as requested by providing technical and regulatory expertise where relevant to enhance BARDA program product development and resolve major concerns and problems that require resolution.