Senior RA Associate Consultant - EU MDR (Medical Devices)

📋 Description

• Collaborate with client regulatory team to collect EU MDR TF/DD documents for maintenance.
• Identify regulatory requirements, standards, guidance, and submission expectations.
• Review and assemble TF/DD documents in PLM and PDF format.
• Create and index PDF bookmarks in PLM via Change Orders.
• Perform QC checks for completeness, pagination, and errors.
• Coordinate with cross-functional teams to obtain CFG/CFS and other docs and respond to health authority inquiries.

🎯 Requirements

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

🎁 Benefits

• Equal opportunity employer; inclusive recruitment; accommodations on request
• Remote option for eligible candidates; 12-month contract
• Global CRO with quality focus and professional development
• Work with major medical device clients and cross-functional teams
• Collaborative culture with ongoing training and growth