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Support Epidemiologist (Medical Device Active Surveillance Program)

Organization Supported: FDA Center for Devices and Radiological Health (CDRH), Office of Clinical Evidence and Analysis (OCEA), Division 2

Position Overview

The Support Epidemiologist supports the medical device active surveillance program within the Office of Clinical Evidence and Analysis (OCEA), Division 2, at the Center for Devices and Radiological Health (CDRH). The incumbent plays a critical role in translating complex epidemiological and statistical analyses into clear, well-organized, and actionable materials that inform the full lifecycle of active surveillance activities — from initial device selection through ongoing safety reporting and final regulatory decision-making. By maintaining rigorous documentation standards and producing high-quality presentation materials, the Support Epidemiologist ensures that surveillance findings are communicated effectively, that the evidentiary record is complete and audit-ready, and that regulatory stakeholders have the information they need to make timely, well-supported decisions that protect public health.

Duties and Responsibilities

The incumbent serves as a support epidemiologist embedded within a multidisciplinary active surveillance team. The primary responsibilities of this role center on the development, maintenance, and organization of presentation materials and records that inform device selection, ongoing safety reporting, and support regulatory decision-making. The position requires close coordination with epidemiologists, biostatisticians, data scientists, and regulatory reviewers.

The contractor shall:

Device Selection Presentations

Develops structured, evidence-based presentation materials to support the prioritization and selection of medical devices for active surveillance monitoring, incorporating data from sources such as MAUDE and RWD sources.
Synthesizes device-specific background information, signal rationale, and epidemiological justification into slide decks and briefing documents tailored for internal review panels and leadership discussions.
Ensures that device selection materials clearly communicate benefit-risk considerations, surveillance feasibility, and data source availability to facilitate informed prioritization decisions.
Maintains version-controlled records of device selection documentation, including meeting notes, rationale summaries, and supporting analytical outputs.

Surveillance Reporting Presentations

Produces recurring and ad hoc surveillance reports and visual summaries that communicate active surveillance findings to internal audiences, including division leadership, cross-functional teams, and program offices.
Translates statistical outputs, epidemiological metrics (e.g., observed-to-expected ratios, incidence rates, time-to-event analyses), and data quality assessments into accessible and visually clear presentation formats.
Maintains a library of standardized reporting templates that promote consistency, reproducibility, and compliance with CDRH documentation standards across surveillance cycles.
Assists in drafting narrative summaries and interpretive commentary to accompany quantitative surveillance results, ensuring scientific accuracy and appropriate characterization of uncertainty and limitations.

Decision-Making Support Presentations

Prepares briefing materials to support potential regulatory actions arising from active surveillance, including signal evaluation summaries, benefit-risk frameworks, and comparative safety analyses.