Regulatory Affairs • Global Registration
Duration: 15 months • Role: Regulatory Affairs Specialist
Triggered by preparing South Korea Medical Device registration paperwork, this task grew into a broader reconciliation problem: country-by-country registration status was scattered across emails, certificates, and spreadsheets, with no single tracker anyone could trust for a status update.
Preparing South Korea's medical device registration surfaced a familiar problem: registration status is only useful as a single source of truth. Split across emails, individual certificates, and spreadsheets, nobody had the real picture of which countries were current, expiring, or missing documentation.
Cross-checked each country's registration status and certificate data against the source registry and Salesforce record, corrected any discrepancies found, and updated the master tracker.
Delivered a consolidated country/registration tracker the team could use for status reporting across all active markets.
Country-by-country registration status is only useful as a single tracker - keeping it split across emails, certificates, and spreadsheets means no one has the real picture.
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