System Engineer

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

The Systems Engineer – Regulatory Documentation & Labeling Translation is responsible for translating and governing medical device IFUs, labeling, and technical documentation in compliance with FDA labeling requirements (21 CFR Part 801) and the Quality Management System (QMS). This role ensures accuracy, technical consistency, and risk preservation across translated materials, maintaining the integrity of warnings, precautions, contraindications, and symbols to protect patient and user safety.

The role partners closely with Regulatory Affairs, Quality, R&D, Clinical, and Localization vendors, and is especially suited to complex electromechanical or robotic medical devices.

Work Location: Bangalore

Work Mode: Hybrid (3 Days in office)

How Youll Create Impact

Regulatory-Compliant Translation

• Translate Instructions for Use (IFUs), labeling, and technical documentation in compliance with 21 CFR Part 801 and internal labeling standards
• Ensure translated content aligns with approved source documents and regulatory intent
• Support global labeling strategies while maintaining U.S. FDA compliance
  
  

• Ensure precise translation of medical, clinical, and technical terminology without altering meaning, intent, or risk information
• Preserve consistency across documents, revisions, and languages
• Maintain alignment between translated content and design, risk, and clinical documentation
  
  

• Maintain clarity and prominence of warnings, precautions, contraindications, and safety symbols
• Ensure safety-critical information remains unambiguous and compliant in all translations
• Partner with Risk Management to ensure alignment with ISO 14971 risk content (as applicable to labeling)\
  
  

• Support translation review, verification, and approval workflows under the QMS
• Coordinate reviews with Regulatory, Quality, and Clinical stakeholders
• Address reviewer feedback and ensure controlled updates through document change processes
  
  

• Maintain traceable, controlled translation records suitable for FDA inspections and internal audits
• Ensure document control, versioning, and approval evidence are complete and inspection-ready
• Support responses to regulatory inquiries related to labeling and translations
  
  

• 4 to 6 years total experience in regulated medical device environments
• Experience supporting global labeling and multilingual documentation
• Experience with robotic systems, capital equipment, or software-driven devices
• Experience collaborating with Clinical or Medical Affairs on safety language
• Certifications in technical communication, quality, or regulatory affairs (preferred)
  
  

• Exceptional attention to detail and documentation rigor
• Strong understanding of medical device labeling and risk communication
• Ability to preserve safety intent across translations
• Clear communication with Regulatory, Quality, Clinical, and Engineering teams
• High ownership for compliance, traceability, and inspection readiness
  
  

• Experience in medical device documentation, labeling, or systems engineering within FDA-regulated environments
• 3+ years of hands-on experience with regulatory-compliant translation of IFUs and labeling
• Demonstrated experience supporting FDA inspections or internal audits related to labeling
• Experience with complex electromechanical devices; robotic medical device experience preferred
  
  

• Electronic Document Management Systems (EDMS) / eQMS (e.g., MasterControl, TrackWise, ETQ)
• Document control, change management (ECO/ECN), and approval workflows
• Labeling lifecycle management tools (where applicable)
  
  

• Translation management systems (TMS) and controlled localization workflows
• Terminology management / glossaries for medical and technical terms
• Collaboration with certified translation vendors and linguists
  
  

• 21 CFR Part 801 (Labeling)
• 21 CFR Part 820 (QSR – document controls, labeling controls)
• ISO 13485 (preferred)
• ISO 14971 (risk content alignment)
  
  

• Technical authoring tools (e.g., structured authoring, XML/DITA – preferred)
• Advanced Excel for tracking, reconciliation, and audit evidence