Senior Regulatory Affairs Consultant

Job Summary

A company is looking for a Sr. Regulatory Affairs Associate Consultant.

Key Responsibilities

• Collaborate with the client's regulatory project team to collect necessary documents for resubmission and maintain understanding of EU MDR and global medical device regulatory requirements
• Review and combine regulatory documents, perform quality control checks, and ensure all documents are approved and up-to-date
• Coordinate with local affiliates for legal documents and communicate project status with the regulatory management team

Required Qualifications

• Bachelor's degree (life sciences preferred)
• Minimum of 1 year of experience in Medical Device Regulatory Affairs or training focused on EU MDR
• Knowledge of FDA Medical Device regulations, ISO 13485, and EU MDD/MDR
• Proficient in Microsoft Office (Word, Excel, PowerPoint)