Regulatory Affairs Expert

GENERAL SUMMARY

The Regulatory Affairs Expert is responsible for developing and executing strategies to support product registrations, entity set‑up and ongoing compliance with country‑specific requirements. Acting as the local subject‑matter expert, the role ensures adherence to applicable regulations, including support to economic operator obligations, and may support both locally marketed products and regulatory activities for global portfolios, through submission, licenses maintenance and regulatory body interactions. The position also drives local regulatory intelligence activities, translates evolving requirements into actionable guidance for the business, and ensures compliance with applicable quality systems and regulations, including 21 CFR Part 820, EU 2017/745 (MDR), UK MDR 2002, ISO 13485, and local frameworks.

PRIMARY DUTIES & RESPONSIBILITIES

• Defines and implements international regulatory strategies to support product registrations, li...