Sr. RA Associate Consultant

📋 Description

• Establish and maintain an understanding of EU MDR and other global medical device regulatory
• Identify applicable regulatory requirements, harmonized standards, guidance documents, and
• Draft, create or update TDs in collaboration with Platform RA SME
• Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF
• Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders
• Perform Quality Control checks in accordance with client procedures, training, and checklists

🎯 Requirements

• Bachelor's degree (life sciences preferred)
• Minimum of 2 years of working experience in Regulatory Affairs focused on EU MDR
• Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory
• Working proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint)
• Self-starter with ability to work in team environment and projects of diverse scope
• Strong organizational skills including attention to detail, good planning and communication skills