Support Epidemiologist (Medical Device Active Surveillance Program)

Tunnell Government Services•Bethesda, MD

About The Position

The Support Epidemiologist supports the medical device active surveillance program within the FDA Center for Devices and Radiological Health (CDRH), Office of Clinical Evidence and Analysis (OCEA), Division 2. Embedded within a multidisciplinary team, the role translates complex epidemiological and statistical analyses into clear, organized, actionable materials that inform device selection, ongoing safety reporting, and regulatory decision-making. The position coordinates closely with epidemiologists, biostatisticians, data scientists, regulatory reviewers, and leadership to ensure findings are communicated effectively and the evidentiary record is complete and audit-ready. The role develops evidence-based device-selection presentations and briefing documents using sources such as MAUDE and real-world data, and prepares recurring and ad hoc reports and visual summaries of surveillance findings. It translates statistical outputs and epidemiological metrics into accessible materials, maintains standardized reporting templates, and helps draft scientifically accurate narrative summaries that address uncertainty and limitations. The Support Epidemiologist also prepares decision-support materials for potential regulatory actions and stakeholder meetings, including signal evaluations, benefit-risk frameworks, and comparative safety analyses. In addition, the role maintains organized surveillance records, establishes document-management procedures, tracks activities and deliverables, provides status updates, and reviews documentation for completeness and consistency in accordance with FDA records-management policies.

Requirements

Master's degree in Epidemiology, Public Health, Biostatistics, Health Services Research, Clinical Research, or a related scientific discipline.
At least 5 years of experience in applied epidemiology, surveillance, or health data analysis; regulatory, clinical, or public health experience is preferred.
Experience interpreting epidemiologic studies, surveillance findings, statistical analyses, and healthcare data.
Proficiency with data visualization and presentation software, such as Microsoft PowerPoint and Excel.
Familiarity with epidemiological and statistical concepts relevant to safety surveillance, including signal detection, confounding, and time-to-event analysis.
Demonstrated ability to develop clear, concise, well-organized technical reports and presentation materials.
Strong scientific writing, editing, and documentation skills.
Experience working with multidisciplinary teams and complex scientific information.
Proficiency in Microsoft Office Suite, especially Word, Excel, PowerPoint, and Teams.
Must be a U.S. citizen or full Green Card holder.

Nice To Haves

Experience supporting FDA, CDRH, CMS, CDC, NIH, VA, DoD, or other federal health agencies.
Familiarity with medical device regulation, postmarket surveillance, and active surveillance methodologies.
Experience working with real-world data, registries, claims databases, electronic health records, or medical device surveillance systems.
Understanding of epidemiologic study designs, signal-detection methodologies, and safety-monitoring practices.
Experience supporting executive communications, regulatory documentation, or scientific publications.
Knowledge of healthcare quality systems, documentation requirements, and audit-readiness practices.
Familiarity with statistical software such as SAS, R, Python, or STATA.

Responsibilities

Develop structured, evidence-based presentation materials to support prioritization and selection of medical devices for active surveillance, incorporating information from sources such as MAUDE and real-world data sources.
Synthesize device background information, signal rationale, and epidemiological justification into slide decks and briefing documents for internal review panels and leadership discussions.
Communicate benefit-risk considerations, surveillance feasibility, and data-source availability in device-selection materials.
Maintain version-controlled device-selection records, including meeting notes, rationale summaries, and supporting analytical outputs.
Produce recurring and ad hoc surveillance reports and visual summaries for division leadership, cross-functional teams, and program offices.
Translate statistical outputs, epidemiological metrics, and data-quality assessments into accessible presentation formats.
Maintain standardized reporting templates to promote consistency, reproducibility, and compliance with CDRH documentation standards.
Assist in drafting narrative summaries and interpretive commentary that accurately characterize quantitative results, uncertainty, and limitations.
Prepare briefing materials for potential regulatory actions, including signal-evaluation summaries, benefit-risk frameworks, and comparative safety analyses.
Develop presentation packages for multi-stakeholder meetings and escalation reviews that describe findings, evidence strength, and next steps.
Coordinate with senior Active Surveillance Leadership and regulatory leads to align decision-support materials with the current evidence base and applicable FDA guidance and evidentiary standards.
Communicate analytical limitations, data-quality considerations, and residual uncertainties in decision-support materials.
Maintain a systematic, audit-ready filing structure for presentations, analytical records, meeting minutes, and correspondence in accordance with FDA records-management policies.
Develop document-organization procedures and naming conventions that support team access, traceability, and retrieval.
Track surveillance activities, pending deliverables, and action items using project-management tools or tracking logs, and provide regular status updates to team leadership.
Conduct periodic reviews of documentation completeness and consistency across surveillance cycles to support quality assurance.