Collaborate with client regulatory team to collect TF/DD docs for EU MDR
Identify regulatory requirements, harmonized standards, and submission expectations
Review, obtain, and compile TF/DD docs in PLM into PDFs
Create and upload bookmarks/indexes of PDFs into PLM via Change Orders
Perform quality control checks per client procedures
Coordinate with cross-functional teams to obtain CFG/CFS and other project documents

🎯 Requirements

Bachelor's degree (life sciences preferred)
4-6 years in Regulatory Affairs focused on EU MDR and Reg Ops
Knowledge of EU MDR, ISO 13485, FDA medical device regulations
Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Strong written and verbal English communication skills

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