Description

You will collaborate with a client's regulatory project team to collect and resubmit technical documentation under EU MDR, perform quality control checks, and communicate with local affiliates. This is a 12-month contract role with a global CRO, offering remote work from Mexico.

Requirements

• Bachelor's degree (life sciences preferred)
• 1+ year experience in Medical Device Regulatory Affairs with EU MDR focus
• Knowledge of FDA regulations, ISO13485, EU MDD/MDR
• Proficient in Microsoft Office (Word, Excel, PowerPoint)
• Strong written and verbal English communication

Responsibilities

• Collect all necessary Technical File/Design Dossier documents for EU MDR resubmission
• Review and combine TF/DD documents in PLM into Adobe PDF files with bookmarks/indexes
• Perform Quality Control checks per client procedures
• Work with local affiliates to respond to queries and obtain legal documents
• Communicate with regulatory management team on project status and deliverables