Global Labeling Specialist

About the role

The Global Labeling Specialist works within Research and Development and will interface with Packaging Engineering, Product Engineering, Product Managers/Marketing, domestic and international Regulatory Affairs, Quality, Purchasing, and Manufacturing. This role is responsible for labeling management for BDI Surgery, including the design, development, approval, and implementation of all product labeling for new and sustaining projects across all manufacturing sites. The labeling function works closely with Regulatory Affairs to ensure compliance with domestic and international regulations.

Responsibilities

• Develops and modifies labeling for product labels, cartons graphics, implant cards, patient leaflets, inserts, and other related material, ensuring compliance with medical, legal, and regulatory requirements for medical devices and drugs, following established design formats, labeling style guidelines, and branding standards.
• Leads and/or supports cross-functional teams to collect labeling content and translate it into functional label layouts using labeling and/or illustrating software.
• Supports assigned project teams on commercialized and new product development products for all associated labeling requirements, with or without supervision.
• Develops and manages labeling changes within the approved document management system.
• Designs product labeling considering factors such as product identification, worldwide requirements, sales appeal, aesthetic quality, printing, and production techniques.
• Manages multiple concurrent deadlines and prioritizes work independently.
• Supports company initiatives as identified by management, including the Quality Management System (QMS), Environmental Management System (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company Policies, Standard Operating Procedures (SOP), working instructions, and task assignments.
• Aids in the design and development of packaging prototypes and supports R&D builds with labeling.
• Participates in Voice of Customer (VOC) activities through collaboration with Key Opinion Leaders (KOLs).
• Develops, maintains, and manages all packaging graphics and labeling using electronic desktop publishing equipment.
• Performs other related duties and responsibilities as assigned.

Requirements

• Degree-level qualification or equivalent combination of education and experience.
• Minimum of 4 days in-office presence per week for on-site collaboration.
• For certain roles, employment is contingent upon sufficient proof of full COVID-19 vaccination. Testing may be available and/or required in some locations. Accommodation requests will be considered pursuant to applicable law.

Skills

Required:

• Proficiency in labeling software and/or illustrating software.
• Ability to manage multiple concurrent deadlines and prioritize work independently.
• Knowledge of FDA regulations and other regulatory requirements for medical devices and drugs.
• Experience with document management systems and electronic desktop publishing equipment.

Benefits

BD offers a comprehensive Total Rewards program, including competitive compensation and benefits. The company is committed to attracting and retaining high-quality talent through reward and recognition opportunities that promote a performance-based culture.

Pay

Salary range: $66,700.00 – $106,700.00 USD annually. The salary offered is determined by role-specific requirements, including skills, education, applicable labor laws, and Collective Bargaining Agreement (CBA) requirements where applicable.

Schedule

This role requires a minimum of 4 days of in-office presence per week.