Identify regulatory requirements, standards, guidance, and submission expectations
Review, obtain, and compile TF/DD documents into Adobe PDF in PLM
Create and upload bookmarks/indexes of PDFs into PLM via Change Orders
Perform QC checks per client procedures, training, and checklists (pagination, completeness)
Coordinate with cross-functional teams to obtain CFG, CFS, and related documents
Respond to inquiries from affiliates and coordinate with management on health authority questions

🎯 Requirements

Bachelor’s degree (life sciences preferred)
Minimum 1 year of Regulatory Affairs experience focused on EU MDR
Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory
Working proficiency in Microsoft Office (Word, Excel, PowerPoint)
Strong written and verbal English communication skills

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