Tech Stack

Description

You will prepare and manage regulatory submissions and documents for medical devices, ensuring compliance with global standards. You'll coordinate applications, handle queries, and maintain documentation to support product registrations and renewals.

Requirements

• Bachelor's degree in Life Sciences or regulatory-related field
• Minimum 1 year Regulatory Affairs experience in medical device industry
• Knowledge of EU MDD/MDR, US FDA QSR, and ISO 13485
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)

Responsibilities

• Prepare and deliver documents for global regulatory registrations, renewals, and tenders
• Coordinate medical device applications and follow up on queries through approval
• Evaluate documents for accuracy and consistency for regulatory submissions
• Perform legalization, notarization, and apostille of regulatory documents
• Submit and manage US FDA Certificates of Foreign Government (CFGs)