International Medical Device Countermeasures (MCM) Data SME

Our client is striving to transform medical device countermeasures (MCM) data management for faster, better-informed regulatory decisions and improved outcomes of future emergencies by relying on its understanding of trusted international regulatory partners and domestic public health entities. This substantial research and development effort requires a subject matter expert (SME) with significant experience in the MCM domain and specializing in data analysis, statistical analysis, data visualization, regulatory science, and international regulatory harmonization and reliance frameworks.

What You Will Do:

• Lead the research, development and integration of an international reliance framework and establishment of Standards community partnership.

• Developing a data collection plan and strategy for the devices of interest.

• Provide insight and guidance in MCM data collection, supporting regulatory science and FDS regulatory roles and processes to support the data model design.

• Design comparative regulatory analysis of standards utilization and international conformity assessment for devices of interest.

• Design and direct statistical analyses and development of voluntary consensus standards databases in coordination with program data scientist.

• Translate evidence based research into a practical international reliance framework, complete with jurisdiction-specific, device-specific, emergency-specific criteria, and cybersecurity considerations.

• Develop an international reliance framework and criteria; Integrate the final framework into existing protocols and coordination procedures/mechanisms such as the EUA process, IDOC activation, and interagency coordination procedures.

• translates the evidence base into a practical international reliance framework, complete with jurisdiction-specific, device-specific, emergency-specific criteria, and cybersecurity considerations.

• Support concept development, requirements analysis, performance metrics, benchmark cases and validation of MCM databases.

• Characterize Standards Development Organization (SDO) landscape and engagement strategy to support standards alignment and international regulatory reliance MCM; Provide quarterly SDO summary reports and partnership recommendations.

What You Will Need:

• Master's or PhD in regulatory science, public health, public policy, or related field.

• Minimum 10 years of experience in medical device regulation

• Deep expertise in international regulatory harmonization and reliance frameworks.

• Demonstrated experience with FDA CDRH premarket pathways (510(k), PMA, De Novo, EUA).

• Knowledge of international regulatory systems (EU MDR, Health Canada, TGA, PMDA, MHRA).

• Experience with Standards Developing Organizations (e.g. ISO, IEC, GMP, ASTM, etc.).

• Experience briefing senior leadership and developing policy and guidance documents

• Strong analytical and writing skills, with experience preparing scientific and leadership presentations.

• Ability to synthesize complex data from multiple sources into actionable insights.

• U.S. citizenship or permanent residency (required for federal contract work).

• Hybrid role requiring the ability to work onsite at the client location in Silver Spring, MD.

What Would Be Nice To Have:

• Prior domain experience in MCM public or military health emergency response (e.g., EUA processes, regulatory operations, interagency coordination (e.g. BARDA, CDC) and data exchanges).

• Experience with post-market surveillance systems, adverse event reporting, and real-world evidence (RWE) datasets.