Labeling specialist

Indotronix Avani Group; Warwick (RI); On-site; USD 65,000 - 90,000; Full time

Job summary

Indotronix Avani Group is seeking a labels specialist to develop and modify labeling for medical devices and drugs, ensuring compliance with FDA and ISO standards. You will lead cross-functional teams to translate labeling content into effective label layouts using labeling and illustration software, while managing multiple deadlines.

The role supports both existing products and new development, collaborates with quality systems, and contributes to packaging prototype design and VOC activities

Qualifications

• Experience with medical device labeling and packaging.
• Knowledge of FDA labeling regulations and ISO/ SOPs.
• Strong attention to detail and project management skills.

Responsibilities

• Develops and modifies labeling for product labels, cartons graphics, implant cards, patient leaflets, inserts and other related material ensuring that they meet all medical, legal, and regulatory requirements for medical devices and drugs following the established design format, labeling style guidelines and branding standards.
• Leads and/or supports a cross-functional team collecting labeling content and translating it into a functional label layout utilizing labeling software and/or illustrating software.
• Works on commercialized and new product development products for all associated labeling requirements.
• Develops and manages labeling changes within the approved document management system.
• Designs product labeling considering such factors as product identification, worldwide requirements, sales appeal, aesthetic quality, printing, and production techniques.
• Manages multiple concurrent deadlines and prioritizes work independently.
• Supports all company initiatives as identified by management and in support of the Quality Management System (QMS), Environmental Management System (EMS), and other regulatory requirements.
• Complies with the U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements including ISO, 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 (KOL’s).
• Develops, maintains, and manages all packaging graphics and labeling utilizing electronic desktop publishing equipment.

Skills

Labeling design

Regulatory compliance

Cross-functional collaboration

Project management

Tools

Labeling software

Illustration software

Job description

• Develops and modifies labeling for product labels, cartons graphics, implant cards, patient leaflets, inserts and other related material ensuring that they meet all medical, legal, and regulatory requirements for medical devices and drugs following the established design format, labeling style guidelines and branding standards.
• Leads and/or supports a cross-functional team collecting labeling content and translating it into a functional label layout utilizing labeling software and/or illustrating software.
• Works on commercialized and new product development products for all associated labeling requirements.
• Develops and manages labeling changes within the approved document management system.
• Designs product labeling considering such factors as product identification, worldwide requirements, sales appeal, aesthetic quality, printing, and production techniques.
• Manages multiple concurrent deadlines and prioritizes work independently.
• Supports all company initiatives as identified by management and in support of the Quality Management System (QMS), Environmental Management System (EMS), and other regulatory requirements.
• Complies with the U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements including ISO, 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 (KOL’s).
• Develops, maintains, and manages all packaging graphics and labeling utilizing electronic desktop publishing equipment.