Labeling Engineer

Job Description • We are seeking a highly skilled Medical Device Labeling Engineer with strong expertise in regulatory compliance, labeling development, and cross-functional coordination. This role also involves onsite leadership and customer engagement, serving as a key liaison between client teams and offshore labeling groups. • The ideal candidate will bring deep knowledge of US & EU labeling regulations, strong project management capabilities, and experience working in a fast-paced, multi-stakeholder environment. Responsibilities: • Labelling Engineering & Compliance: • Develop, review, and maintain labeling content including IFUs, packaging labels, inserts, and e-labeling. • Ensure compliance with global regulations and standards: • FDA (21 CFR Part 801 & 820) • EU MDR • ISO 13485, ISO 20417, ISO 15223 • Support product lifecycle activities with labelling expertise. • Conduct labeling risk assessments and mitigation planning. • Maintain labeling documentation, version control, and DHF compliance. • Support audits, inspections, and notified body interactions. Onsite Leadership & Project Coordination: • Plan, schedule, and lead labeling implementation activities for assigned product lines. • Develop and manage EU MDR labeling plans, including timelines, risks, and dependencies. • Ensure readiness of labeling documentation for submissions, audits, and responses. • Act as the primary point of contact between customer and offshore teams. • Track milestones and provide status reports, dashboards, and updates. Cross-Functional Collaboration: • Work closely with Regulatory, Quality, R&D, Manufacturing, Operations, and Marketing teams. • Coordinate with translation vendors, technical writing teams, and offshore labeling teams. • Support change management activities (IFU updates, packaging, BOM changes). • Assist in Notified Body deficiency responses. • Partner with Manufacturing to ensure smooth label implementation. • Align labeling with customer branding and product requirements. Change Management & Governance: • Support change orders and documentation approvals. • Evaluate change requests and coordinate with offshore teams. • Review SOPs, templates, and labeling standards. • Analyze impact of regulatory updates (e.g., EU MDR) across product lines. Required Qualifications: • Bachelor's degree in engineering, Biomedical, Life Sciences, or related field. • 5-10 years of experience in medical device labeling or documentation engineering. • Strong knowledge of: • FDA 21 CFR Part 801 & 820 • EU MDR • ISO 13485, ISO 20417, ISO 15223 • Experience with PLM/document control systems (Windchill, Agile, SAP, etc.) • Proven experience in customer-facing / onsite roles • Strong communication, stakeholder management, and organizational skills. Preferred Qualifications: • Experience with labeling/graphics tools: Loftware, Bartender, P360. • Familiarity with Adobe Illustrator, InDesign. • Knowledge of UDI (Unique Device Identification). • Experience with eIFU platforms. • Exposure to Class II/III devices or Cardiac Surgery domain. • Experience working in onsite-offshore/global delivery models.