Senior Associate - Regulatory Affairs (EU MDR)

📋 Description

• Collaborate with regulatory team to gather EU MDR docs
• Identify applicable regulatory requirements, standards, guidance
• Review and compile TF/DD docs into PDFs in PLM
• Create bookmarks/index PDFs and upload via Change Orders
• Perform QC checks for completeness, pagination, blanks
• Coordinate with cross-functional teams for CFG/CFS and docs

🎯 Requirements

• Bachelor's degree (life sciences preferred)
• At least 1 year in Regulatory Affairs focused on EU MDR
• Knowledge of EU MDR, ISO 13485, and FDA Medical Device regulations
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Strong written and verbal English communication skills