Labeling Engineer

• 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.

• 510 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 onsiteoffshore/global delivery models.