Allison Scott, RAC, has over a decade of experience as a consultant providing regulatory support to U.S. and global health information technology, medical device, diagnostics, and combination product companies. Allison is an associate director in the Healthcare and life sciences disputes, regulatory, compliance, and investigations practice at Navigant, where clients regularly leverage her expertise across the product life cycle, from securing initial U.S. Food and Drug Administration approval to addressing post-market issues that may arise.
Allison has obtained U.S. regulatory clearances and approvals and Canadian licensing for international and domestic firms for a wide range of products, including medical software, diagnostic monitoring and imaging equipment, and active therapeutic devices and orthopedic implants. Allison also has secured humanitarian use device certifications, humanitarian device exemptions, and investigational device exemptions for multiple products in the U.S. and Canada. In the post-market space, she has provided support to companies needing assistance with compliance issues related to Unique Device Identification, recalls, adverse events, medical device reporting, and complaint handling.
In addition to Allison’s regulatory experience, she has assisted various pharmaceutical and medical device companies in the review of their compliance programs, including Sunshine Act-related distributor interviews and transaction reviews, audits of distributor and sales representative spending and reporting, and commercial and medical field force monitoring.