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 regulations (21 CFR Part 801 & 820)
Expertise in EU MDR and ISO standards (13485, 20417, 15223)
Hands-on experience with PLM systems and document control tools (e.g., Windchill, Agile, SAP)
Proven ability to lead onsite, customer-facing roles in labeling initiatives
Excellent written, verbal, and stakeholder communication skills
Responsibilities
Develop and maintain labeling content including Instructions for Use, packaging labels, and product inserts
Ensure compliance of labeling with global regulations and standards
Support product development by providing expert labeling guidance
Conduct risk assessments and mitigate use-related risks
Plan and coordinate labeling implementation activities for assigned product lines
Serve as the primary labeling point of contact with customers
Collaborate with cross-functional teams to ensure effective labeling execution
Benefits
Supportive of professional development and continuing education
Opportunities to lead initiatives and projects
Engagement with diverse stakeholders in a global environment
Exposure to cutting-edge medical device technologies
Potential for career advancement within a dynamic organization
Full Job Description
Job Description:
We are seeking a highly skilled and detail-oriented Medical Device Labelling 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 labelling, 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.
