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KH

Labeling Engineer

Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
5 months ago
  • Regulatory Compliance
  • Technical Writing
  • Change Management
  • Windchill
  • Agile
  • SAP
  • Illustrator
5 months ago
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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.

Labeling Engineer · Katalyst Healthcares & Life Sciences

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