Bachelor's degree in Engineering, Biomedical, Life Sciences, or a related field.
5-10 years of experience in medical device labeling or documentation engineering.
Strong 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 like Windchill or Agile.
Proven customer-facing role experience and leadership in labeling initiatives.
Excellent written and verbal communication skills with stakeholders.
Strong organizational skills with high attention to detail.
Responsibilities
Lead labeling engineering and compliance activities.
Develop and maintain labeling content including IFUs and packaging labels.
Ensure global regulatory compliance for labeling documentation.
Conduct risk assessments and manage labeling documentation.
Plan and coordinate labeling implementation at customer sites.
Serve as primary contact between customers and internal teams.
Collaborate across functions to ensure smooth project execution.
Benefits
Opportunity to lead onsite labeling initiatives and customer interactions.
Engagement in global medical device programs with diverse teams.
Development of specialized knowledge in labeling compliance and regulations.
Collaboration with cross-functional teams across multiple disciplines.
Full Job Description
Job Description:
We are seeking a highly skilled and detail-oriented Medical Device Labeling Engineer with experience in onsite leadership and customer coordination to support global medical device programs. The ideal candidate will have 5-10 years of experience in medical device labeling, regulatory compliance (US and EU), and cross-functional project execution.
In addition to core labeling engineering responsibilities, this role requires planning, coordination, and leadership of labeling implementation activities at customer sites, serving as a primary point of contact between the customer and offshore labeling teams. The position demands strong regulatory knowledge, project management capabilities, and the ability to work effectively in a multi-stakeholder, fast-paced environment.
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.
Coordinate with translation vendors, Technical Communications teams, and offshore labeling teams for final labeling execution.
