Senior Labeling Specialist

COMPANY DESCRIPTION

At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us!

POSITION SUMMARY

The Senior Labeling Specialist is responsible for managing, developing, and coordinating the creation, revision, and release of product labeling materials from start to finish. This role ensures that all labeling complies with regulatory standards, company policies, and international requirements. The Senior Labeling Specialist will proactively recognize and prioritize new assignments, drive labeling decisions, and effectively communicate deadlines while collaborating with the labeling team to ensure timely execution. The position requires strong leadership, communication, and project management skills to facilitate seamless cross-functional coordination.

POSITION QUALIFICATIONS

Knowledge: 

• Ability to lead and implement cross-functional projects, develop project schedules, and communicate project status.
• Strong interpersonal skills, including effective verbal and written communication.
• Strong communication skills.
• Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies – able to do so quickly without sacrificing attention to detail.
• Strong technology skills and abilities, especially with Microsoft Office programs and web-based programs.
• Ability to interact effectively with functions of a global organization to achieve goals.

Level of Experience:  

• Minimum of 8 years of experience in medical device labeling.
• Comprehensive knowledge of labeling regulations, including FDA, EU MDR, and ISO standards.
• Proficiency in labeling software and quality management systems (e.g., Loftware, Grand Avenue).
• Strong technical writing and documentation skills.
• Excellent attention to detail and problem-solving abilities.
• Strong communication and project management skills.
• Demonstrated ability to manage multiple projects from start to finish, ensuring alignment with deadlines and quality standards.
• Ability to work collaboratively and drive projects independently.

Level of Education:

• Bachelor’s degree in a related field (e.g., Life Sciences, Engineering, Technical Writing) or equivalent work experience. 

Travel: Up to 10% of travel is required or expected for the Senior Labeling Specialist.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Lead and manage the development, review, and approval of product labeling, including labels, Instructions for Use (IFU), and other regulatory documents from initiation to completion.
• Ensure labeling is compliant with applicable regulations (e.g., FDA, EU MDR, ISO standards) and internal quality standards.
• Oversee labeling change control processes, including creation and review of Document Change Requests (DCRs).
• Maintain accurate labeling documentation within the Quality Management System (QMS) and manage records in systems such as Grand Avenue.
• Proactively recognize and take ownership of new labeling assignments, assessing project requirements and aligning resources.
• Communicate effectively with cross-functional teams to drive labeling decisions and provide clear timelines and expectations.
• Coordinate project timelines, set milestones, and monitor progress to ensure labeling projects meet established deadlines.
• Conduct peer reviews and provide technical guidance for labeling projects.
• Create and update Required Label Specifications (RLS) and ensure proper approval routing.
• Perform label artwork verification and proofing to identify and correct errors.
• Coordinate with suppliers and external vendors on labeling requirements and obtain necessary approvals.
• Support training initiatives by developing and delivering training materials related to labeling processes.
• Identify and implement process improvements to enhance labeling efficiency and compliance.

OTHER RESPONSIBILITIES

Experience with UDI (Unique Device Identification) and GTIN (Global Trade Item Number) management.

• Familiarity with regulatory submission processes.
• Knowledge of multilingual labeling and translation processes.
• Loftware Spectrum.

QUALITY POLICY

At AirLife, Quality is our promise.  It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.

DEIA STATEMENT
At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.