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FDA CDRH -- October 2026

Biomedical Engineer – Regulatory Scientific Reviewer (MedSun Analyst)

Position Title: Biomedical Engineer/Regulatory Scientific Reviewer – MedSun Analyst

Employment Type: Full-Time Employee

Schedule: Monday–Friday, excluding holidays

Position Summary

The Biomedical Engineer / Regulatory Scientific Reviewer (MedSun Analyst) provides scientific, engineering, and regulatory support to FDA's Center for Devices and Radiological Health (CDRH) Total Product Life Cycle (TPLC) oversight activities. The incumbent supports post market surveillance initiatives through the review, analysis, and interpretation of real-world medical device performance and safety data, including advanced analytic-generated signal alerts from FDA's Medical Data Enterprise.

The position plays a role in the operation and management of FDA's Medical Product Safety Network (MedSun), a nationally recognized surveillance program established under Section 519(b)(5)(A) of the Federal Food, Drug, and Cosmetic Act. MedSun connects FDA with more than 300 healthcare facilities nationwide to identify emerging medical device safety and quality issues and support timely, evidence-based regulatory decision making.

The Biomedical Engineer / Regulatory Scientific Reviewer serves as a technical subject matter expert, applying engineering principles, clinical knowledge, and post market surveillance expertise to assess medical device safety, effectiveness, quality, and performance concerns.

Essential Duties and Responsibilities

Medical Device Surveillance and Signal Evaluation

Review, assess, and triage automated signal alerts generated through FDA's Medical Data Enterprise and other surveillance systems
Analyze medical device adverse event reports, safety signals, trends, and emerging issues to identify potential public health concerns
Evaluate complex scientific, clinical, engineering, and operational data related to medical device performance, safety, and effectiveness
Contribute to Total Product Life Cycle (TPLC) oversight activities through evidence-based assessment and interpretation of post market data
Support the identification, validation, prioritization, and management of potential safety signals requiring regulatory review

MedSun Program Operations

Support the day-to-day operation of the MedSun network and engagement with participating healthcare facilities
Serve as a liaison between FDA and MedSun user facilities to facilitate reporting and information exchange regarding medical device safety issues
Conduct outreach activities, information gathering, and follow-up investigations with healthcare providers and clinical engineering personnel
Assist with development of MedSun communications, reports, educational materials, and presentations
Promote high quality reporting and surveillance activities among participating facilities

Scientific and Regulatory Review

Review medical device incident reports, complaint data, recall information, and related surveillance data
Conduct technical evaluations of device-related incidents and system failures
Perform root cause analyses and assist with investigations involving medical device-related adverse events
Apply risk management methodologies, including failure mode and effects analysis (FMEA), hazard assessment, and mitigation strategies
Prepare scientific reviews, briefing materials, technical memoranda, and regulatory recommendations for FDA leadership and multidisciplinary review teams
Provide objective, well-supported scientific interpretations to support regulatory decision making