International Medical Device Countermeasures (MCM) Data SME
Core
Lead research and development of an international reliance framework for medical device countermeasures (MCM) to support faster regulatory decisions and emergency outcomes.
Role type
Senior IC regulatory science subject matter expert (MCM data)
Builds
International reliance frameworks, data collection strategies, and voluntary consensus standards databases for medical devices
Domain
Public health / Medical device regulation / International regulatory harmonization
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
International regulatory harmonization, FDA premarket pathways (510k, PMA, De Novo, EUA), EU MDR, Health Canada, TGA, PMDA, MHRA, Standards Developing Organizations (ISO, IEC, GMP, ASTM), statistical analysis, data visualization, regulatory science, policy development, briefing senior leadership
Preferred skills
MCM public or military health emergency response, post-market surveillance, adverse event reporting, real-world evidence (RWE) datasets
Technologies
None explicitly stated
Responsibilities
Lead research, development, and integration of an international reliance framework; Develop data collection plans and strategies for devices of interest; Design comparative regulatory analysis of standards utilization; Direct statistical analyses and development of voluntary consensus standards databases; Translate evidence-based research into practical international reliance frameworks with jurisdiction-specific criteria; Characterize Standards Development Organization (SDO) landscape and engagement strategy
Seniority
Senior, hands-on IC