Overview

Senior regulatory affairs role plays a critical part in enabling the global commercialization of innovative in vitro diagnostic products and software solutions. You will shape and execute regulatory strategies ensuring timely market access across multiple global regions, guiding complex submissions and supporting product development from a compliance perspective.

Responsibilities

• Lead the preparation, authoring, and submission of global regulatory filings, including technical files, registrations, listings, and submissions required for product approvals.
• Collaborate with international regulatory counterparts to ensure timely and compliant submission of documentation across multiple global markets.
• Provide regulatory guidance and approval for design control deliverables, product development documentation, protocols, reports, and marketing materials.
• Assess regulatory risks and interpret evolving global regula...