International Medical Device Countermeasures (MCM) Data SME

About the role

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.

Responsibilities

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

Requirements

• 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.

Qualifications

• 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.

Skills

• Ability to obtain Public Trust clearance.

Benefits

• The annual salary range for this position is $98,000.00-$163,000.00.
• Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Pay

• The annual salary range for this position is $98,000.00-$163,000.00.

Schedule

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