Lead Systems Engineer - Registration Documentation (Healthcare/medical devices)

Overview

Lead Systems Engineer - Registration Documentation coordinates and provides access to product technical documentation needed for global regulatory registrations, renewals, and market access for Radiometer.

What you'll do

• Act as the primary R&D point of contact for International Registrations on technical documentation for product registrations.
• Maintain, organize, and continuously improve the documentation library for international registration activities.
• Identify, collect, review, and provide technical documentation for worldwide registrations, renewals, and regulatory submissions.
• Collaborate with Regulatory Affairs, International Registrations, Systems Engineering, and Product Development to keep documentation complete, accurate, and up to date.
• Serve as the R&D point of contact for Unique Device Identification (UDI) data and documentation.
• Improve documentation processes while protecting confidential information and intellectual property.

What you'll need

• Bachelor’s degree in Engineering, Life Sciences, or a related scientific discipline.
• 10+ years of experience in medical device development, Regulatory Affairs, Quality Assurance, Technical Documentation, or a related function in a regulated environment.
• Understanding of medical device regulatory requirements including MDR, IVDR, FDA, or comparable international frameworks.
• Experience with medical device design documentation including requirements, risk management, verification and validation, and product lifecycle documentation.
• Experience managing controlled documentation systems and retrieving information from complex technical documentation sets.

Details

• Location: Bangalore, Karnataka, India.
• Reports to the Engineering Manager.
• On-site role, part of the R&D Systems Engineering - PLM department in Bengaluru.