Our client, a Global Medical Device Manufacture, has an immediate opening for a Regulatory Labeling Specialist for an 18-month+ contract opportunity. Our client offers results-driven people a place where they can make a difference every day!  You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment.  

Position Description

Collaborates with product subject matter experts to gather and assess labeling content. Executes label format and compiles content using specialized software. Audience for labels includes hospital and healthcare staff in global markets. Labels must comply with medical device regulations, standards, and business requirements.

Key Responsibilities:

• Developing and maintaining medical device labels in compliance with regulations, standards, and business requirements.
• Collaborating with product subject matter experts (SMEs) from Regulatory Affairs, Product Development, Safety Engineering, Packaging Engineering, Clinical Sciences, Marketing, and Trade Compliance to assess and determine labeling requirements and content.
• Participating in new product label planning meetings and capturing requirements using quality system planning documents.
• Designing label formats for functional usability by hospital and healthcare staff in global markets.
• Using specialized labeling software to generate label templates and enter data, text, and graphics into a print-on-demand label database.
• Using desktop publishing software to design externally produced labels.
• Ensuring barcodes pass verification testing and selecting appropriate label materials in collaboration with packaging engineers.
• Supporting label translation strategies to meet international regulatory and user needs.
• Managing multiple concurrent labeling projects, including both new product development and label maintenance.
• Reviewing labels for completeness, accuracy, and presentation-including labels created by other team members.
• Contacting external suppliers to resolve technical labeling output requirements.
• Managing labels in a PLM/CMS system for controlled label releases and revision tracking.
• Managing work to align with project milestones and communicating progress to project managers.
• Informing project managers about the impact of translation on label design, timeline, and cost.
• Collecting and tracking metrics associated with labeling projects.
• Reviewing regulatory documentation to verify that medical device labeling references are complete, correct, and compliant with FDA and EU requirements.

Qualifications:

• Bachelor's Degree required; a degree in a science, engineering, or graphic design-related field is preferred.
• Strong understanding of labeling regulations and standards in the medical device industry.
• Experience using labeling and desktop publishing software.
• Excellent organizational skills and the ability to manage multiple concurrent projects.
• Strong written and verbal communication skills, including the ability to collaborate effectively with cross-functional teams.
• High attention to detail with a commitment to compliance and quality.
• Ability to work independently and drive tasks to completion with minimal supervision.
• Experience with PLM/CMS systems for document and revision control is preferred.
• Familiarity with global labeling regulations and language translation processes is a plus.
• Knowledge of barcode verification processes and print-on-demand systems is preferred.
• Experience with international labeling requirements and translation management systems is a plus.