Labeling and Technical Publications

Job Description

Designation: Staff Specialist Labeling & Technical Publications Experience: 7–11 years Location: Gurgaon (GGN) or Bangalore (BLR) Interview Rounds: 8 Work Mode: Hybrid / Onsite Role Overview We are seeking a highly skilled professional to manage and coordinate global labeling and technical publications for medical device products. This role involves regulatory documentation, translation workflows, quality compliance, and cross-functional project leadership within a regulated environment. Key Responsibilities Manage and approve labeling jobs using tools like Microsoft Teams Planner and PLM systems. Coordinate document translations with external vendors and ensure regulatory compliance. Publish approved documents to global portals and maintain accurate versions. Lead and support Engineering Change Requests (ECR/ECN) related to labeling and documentation. Act as the local labeling lead for global projects, tracking progress, managing stakeholders, and reporting risks. Ensure compliance with global quality and regulatory standards (EU MDR, ISO 14971, IEC 62366). Support risk management processes and integrate risk measures into product labeling. Review quality assurance documentation related to product sustenance and lifecycle management. Manage label printing for regulatory submissions and large-scale updates. Must-Have Skills & Qualifications 7–11 years of work experience, with 5+ years in technical writing, labeling, or quality assurance in the medical device domain. Hands-on experience with documentation systems such as onePLM, SharePoint, or similar. Solid understanding of regulatory frameworks including EU MDR, ISO 14971, and IEC 62366. Strong project management capabilities with the ability to manage multiple projects and timelines. Bachelor’s degree in Engineering, Science, or a related technical field. Excellent communication and stakeholder management skills.