Labeling Engineer

Responsibilities

• Labeling Engineering & Compliance
• Develop, review, and maintain labeling content including Instructions for Use (IFU), packaging labels, product inserts, and electronic labeling.
• Ensure labeling compliance with global regulations and standards including: FDA (21 CFR Part 801 & 820). EU MDR. ISO 13485, ISO 20417, ISO 15223.
• Support product development and lifecycle activities by providing expert labeling guidance.
• Conduct labeling risk assessments and ensure mitigation of use-related risks.
• Maintain labeling documentation, version control, and design history files as per quality system requirements.
• Participate in and support audits, inspections, and notified body interactions related to labeling.
• Onsite Labeling Lead & Project Coordination
• Plan, schedule, coordinate, and lead labeling implementation activities for assigned product lines or Operating Units (OU).
• Develop and manage integrated EU MDR labeling plans, including activities, timelines, risks, dependencies, and opportunities.
• Ensure readiness of labeling documentation and samples for Notified Body submissions, audits, and deficiency responses within defined timelines.
• Serve as the primary labeling point of contact between the customer and company, providing interpretation of EU MDR, global regulations, and customer-specific requirements.
• Track, monitor, and adjust master schedules and priorities to ensure project milestones are achieved.
• Provide project status reporting, dashboards, and ad-hoc reports to customer and internal stakeholders.
• Cross-Functional & Stakeholder Collaboration
• Collaborate with Regulatory Affairs, Quality, R&D, Operations, Manufacturing, Marketing, Supplier Quality, and Core Team Leads.
• Cookordination with translation vendors, Technical Communications teams, and offshore labeling teams for final labeling execution.
• Represent labeling/graphics on change orders (e.g., IFU changes, BOM changes, PSL, packaging changes).
• Support Notified Body deficiency response drafting in collaboration with offshore teams and other functions.
• Partner with Manufacturing and Operations to ensure smooth label implementation and resolve technical issues.
• Establish and maintain working relationships with suppliers and Supplier Quality teams to support label verification activities.
• Drive customer branding alignment and assess branding impacts on labeling for assigned operating units.
• Change Management & Governance
• Support change order development, including preparation of documents for customer labeling approvers.
• Assess change requests and manage resource allocation with offshore labeling teams.
• Review and approve project plans, SOPs, templates, and labeling standards with key stakeholders.
• Support leadership in analyzing the impact of EU MDR data or regulatory updates on labeling across products and programs.

Qualifications

• Bachelor's degree in Engineering, Biomedical, Life Sciences, or a related field.
• 5+ years of experience in medical device labeling or documentation engineering.
• Strong working knowledge of: FDA 21 CFR Part 820 & 801 EU MDR ISO 13485, ISO 20417, ISO 15223.
• Hands-on experience with PLM systems and document control tools (e.g., Windchill, Agile, SAP).
• Proven ability to work in customer-facing onsite roles and lead labeling initiatives.
• Excellent written, verbal, and stakeholder communication skills.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities.