Summary
Responsible for creating clear, accurate, and compliant labeling materials such as product labels, instructions for use (IFUs), and packaging inserts. They ensure adherence to global regulatory standards (e.g., FDA, EU MDR), collaborate with cross-functional teams (e.g., regulatory, engineering, marketing, PLM, quality), and manage the review and approval processes. Additionally, they manage labeling documentation, track revisions, and continuously improve labeling processes to ensure quality, safety, and regulatory compliance.
Key Duties and Responsibilities (Other duties may be assigned.)
Regulatory Compliance and Documentation
- Ensure Compliance: Ensure labeling content complies with global regulatory requirements (e.g., FDA, EU MDR, ISO 13485, etc.) and meets local language and format standards.
- Stay Updated on Regulatory Changes: Stay informed about changes to relevant medical device regulations and standards and ensure that the labeling documentation reflects these changes.
- Collaborate with Regulatory Affairs and Legal Teams: Work closely with regulatory affairs, legal, and quality assurance teams to verify that labels and instructions for use meet all legal and regulatory obligations.
Writing and Editing Labeling Materials
- Develop and Write Labeling Content: Create, write, and edit high-quality, clear, concise, and accurate labeling materials for medical devices, including product labels, user manuals, instruction guides, and packaging inserts.
- Simplify Complex Information: Translate complex technical information into user-friendly language that is easily understandable for target audiences (e.g., healthcare professionals, patients).
- Ensure Consistency: Maintain consistent terminology, style, and format across all documentation, ensuring alignment with company guidelines and industry standards.
Cross-Functional Collaboration
- Collaborate with Design and Engineering Teams: Work with product development, engineering, and design teams to understand product specifications, functionality, and key messages that should be included in the labeling.
- Work with Marketing and Clinical Teams: Coordinate with marketing and clinical teams to ensure that the labeling conveys accurate and appropriate product trademarking and branding.
Labeling Review and Approval Process
- Manage Review Cycles: Lead and coordinate the review and approval process for labeling materials, ensuring that all internal stakeholders (e.g., regulatory, engineering, marketing, PLM, quality) have reviewed and signed off.
- Track Changes: Maintain and track revisions to ensure accurate and timely updates to labeling materials, ensuring that version control is in place.
Risk Management and Quality Assurance
- Identify and Address Risks: Participate in risk management activities, such as reviewing the impact of labeling on patient safety, usability, and device performance.
- Quality Control: Ensure that all labeling materials meet high-quality standards, including error-free content, appropriate visual design, and accurate information.
Project Management
- Lead Labeling Projects: Manage multiple labeling projects simultaneously, ensuring that deadlines are met, and quality standards are maintained.
- Track Milestones and Deliverables: Maintain schedules for labeling tasks and deliverables, ensuring coordination with product development timelines and launch dates.
Continuous Improvement
- Evaluate and Improve Processes: Continuously evaluate and improve labeling processes to increase efficiency, accuracy, and compliance with regulatory standards.
Job Specifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required Education and Experience
Associate's degree (A. A.) or equivalent from two-year college or technical school and four years of related experience and/or training; or equivalent combination of education and experience with technical writing in the medical device sector.
Other Helpful Knowledge, Skills and Abilities
Attention to Detail — Job requires being careful about detail and thorough in completing work tasks.
- The ability to communicate information and ideas in writing so others will understand.
- The ability to listen to and understand information and ideas presented through spoken words and sentences.
- The ability to see details at close range (within a few feet of the observer).
- The ability to speak clearly so others can understand you.
- Keeping up-to-date technically and applying new knowledge to your job.
- The ability to provide training and information about the safety and proper operation of equipment and systems.
- The ability to read and understands written instructions.
- Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
- Computer skills to include proficiency in Microsoft Office software and Adobe InDesign, Photoshop and Illustrator.
- Knowledge of MadCap Software programs desired, but not required.
Physical Demands necessary to perform this job
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand and walk. Specific vision abilities required by this job include close vision. The employee must lift and carry up to 50 pounds.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
The noise level in the work environment is usually moderate.
