ROLE
– Manages and maintains regulatory data within SAP ERP, including regulatory blocks, releases, and accurate tracking of blocked/released products to support timely customer delivery.
– Drives continuous improvement initiatives using DBS tools, working cross-functionally to enhance regulatory databases, reporting, and system efficiencies.
– Ensures compliance with QMS requirements through accurate documentation, proper filing, SOP maintenance, standard work execution, and data completeness reviews.

REQUIREMENTS
– Bachelor’s degree in field with 5+ years of related work experience or Master’s degree in field with 3+ years of related work experience
– Familiarity with global regulatory frameworks and product registration processes within IVD diagnostics.

BENEFITS
– Comprehensive and competitive benefit programs
– Health care program
– Paid time off