Job Family:Scientist
Travel Required:Up to 10%
Clearance Required:Ability to Obtain Public Trust
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.
The annual salary range for this position is $98,000.00-$163,000.00. Compensation decisions depend on a wide range of factors, including but not limited to skill sets, experience and training, security clearances, licensure and certifications, and other business and organizational needs.
What We Offer: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.
Benefits include:
- Medical, Rx, Dental & 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 & Dependent Care Flexible Spending Accounts
- Transit and Parking Commuter Benefits
- Short-Term & Long-Term Disability
- Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities
- Employee Referral Program
- Corporate Sponsored Events & Community Outreach
- Care.com annual membership
- Employee Assistance Program
- Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)
- Position may be eligible for a discretionary variable incentive bonus
