We are looking for Healthcare & FDA Regulatory Law Expert candidates for a project delivered through the hiring partner.
What you'll do
- Review and evaluate AI-generated responses to U.S. healthcare law hypotheticals, including HIPAA privacy and security rules, Anti-Kickback Statute safe harbors, Stark Law exceptions, and FDA approval pathways (510(k), PMA, NDA).
- Apply a structured legal rubric to assess issue spotting, accuracy of healthcare regulations, and proper application of CMS guidance and FDA rules.
- Identify gaps in AI reasoning around fraud and abuse compliance, clinical trial regulations, telehealth law, and pharmacy benefit management.
- Provide detailed, high-quality annotations and written feedback to refine AI models.
- Collaborate with researchers and project managers to align evaluation standards and project goals.
What you need
- Juris Doctor (J.D.) from an accredited U.S. law school; Bar admission (active/inactive).
- 3+ years of U.S. legal practice in healthcare law, FDA regulatory affairs, or healthcare compliance.
- Strong reasoning skills across HIPAA, the Anti-Kickback Statute, Stark Law, False Claims Act, and FDA regulations.
- Excellent written communication and attention to detail.
Nice to have
- High ethical standards; interest in AI is a plus.
Expertise
Healthcare complianceFDA drug/device approvalAnti-Kickback Statute analysisHIPAA enforcementStark Law exceptionsFalse Claims Act liabilitypre-market approval pathwaysHIPAA privacy and security rulesFDA approval pathways (510(k), PMA, NDA)fraud and abuse complianceclinical trial regulationstelehealth law
Also listed: critical thinking, problem solving.
Who you work with
Project and contracting process: the hiring partner. Applications continue on the provider's website.
Pay and hours
This role does not publish a rate, for 10 to 30 h/week. The work is remote.
Who can apply from where
The provider has not confirmed country eligibility. Check the original offer before applying. With a profile, Tier1 checks your country and languages against this role and every other before you apply.