Job Summary

• Assists in implementing comprehensive regulatory strategies by collaborating with regulatory and cross-functional subject matter experts (SMEs) to ensure alignment with company objectives and compliance with relevant regulations for limited scope typically smaller and less complex projects.
• Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) related activities, maintaining processes for regulatory filings/ licenses and developing technical contribution.
• Keeps abreast of regulatory procedures and changes, participates in process improvement activities related to internal regulatory processes, as well as evolving Regulatory Agency changes.

Matching Summary

Skills & Requirements

Key Requirements

• Bachelor's Degree in Biomedical Engineering, Health Sciences, Pharmaceutical
• minimum 5-6 years of experience in Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent
• RAPS RAC certification

Work Rights