International Medical Device Countermeasures; MCM Data SME

Job Overview

Scientist – lead the research, development and integration of an international reliance framework for medical device countermeasures (MCM) data management. The role requires a public‑trust clearance and supports advisory and regulatory functions across domestic and international partners. Travel up to 10% is expected.

• Lead research, development, and integration of an international reliance framework and establish Standards community partnerships.
• Develop a data collection plan and strategy for devices of interest.
• Provide insight and guidance in MCM data collection, supporting regulatory science and FDS regulatory processes to inform data model design.
• Design comparative regulatory analysis of standard utilization and international conformity assessment for devices of interest.
• Design and direct statistical analyses and develop voluntary consensus standards databases in coordination with the program data scientist.
• Translate evidence‑based research into a practical international reliance framework, including jurisdiction‑specific, device‑specific, emergency‑specific criteria, and cybersecurity considerations.
• Integrate the final framework into existing protocols and coordination 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 develop an engagement strategy to support standards alignment and international regulatory reliance.
• Provide quarterly SDO summary reports and partnership recommendations.

• Master’s or PhD in regulatory science, public health, public policy, or a 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 pre‑market pathways (510(k), PMA, DeNovo, 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 onsite work at the client location in Silver Spring, MD.

• Prior domain experience in MCM public or military health emergency response (e.g., EUA processes, regulatory operations, interagency coordination with BARDA, CDC, and data exchanges).
• Experience with post‑market surveillance systems, adverse event reporting, and real‑world evidence (RWE) datasets.

The annual salary range is $98,000.00–$. Compensation decisions depend on skill set, experience, qualifications, security clearances, licensure, certifications, and other organizational factors.

• Medical, Rx, dental, and vision insurance
• Personal and family sick time; company‑paid holidays
• Parental leave
• 401(k) retirement plan
• Group term life and travel assistance
• Voluntary life and AD&D insurance
• Health savings account, health care and dependent care flexible spending accounts
• Transit and parking commuter benefits
• Short‑term and long‑term disability
• Tuition reimbursement, personal development, certifications and learning opportunities
• Employee referral program
• Corporate‑sponsored events and community outreach
• annual membership
• Employee assistance program
• Supplemental benefits via Corestream (critical care, hospital indemnity, accident insurance, legal assistance and  protection, etc.)
• Potential discretionary variable incentive bonus

Guidehouse is an Equal Opportunity Employer—protected veterans, individuals with disabilities, and any other basis protected by law. Guidehouse will consider qualified applicants with criminal histories in a manner consistent with applicable law and ordinance, including the Fair Chance Ordinances of Los Angeles and San Francisco.