Job DescriptionDesign, develop and update global labeling documents to include product labels, instructions for use (IFUs), implant cards, specifications and technical documentation. Job duties:
- Designs, develops and implements changes to new and existing product labels and instructions for use (IFUs).
- Collaborates with labeling change request initiators to understand requirements, design solutions, timelines and deliverables.
- Creates data-based labels, static pre-printed labels, IFUs and implant cards using labeling software.
- Develops standardized and optimized label templates and identifies issues associated with design.
- Ensures labeling compliance with quality management system (QMS), regulatory requirements and guidelines, standard operating procedures and work instructions.
- Effectively collaborates with cross-functional groups and stakeholders for successful implementation of labeling designs and changes.
- Coordinates with suppliers and vendors for outsourced printed products and translated materials.
- Supports investigations, root cause analysis and corrective action to address labeling non-conformances.
- Supports labeling initiatives collaborating with individuals from functional groups to provide solutions and meet objectives.
- Performs other responsibilities as assigned.
Qualifications- Bachelor's Degree in related field or equivalent experience.
- Three (3) years of experience in a medical device or pharmaceutical FDA regulated environment producing technical documentation.
- Three (3) years of experience in labeling and digital design software platforms, including labeling database management.
- High level of attention to detail and sustained focus.
- Project management skills and experience.
- Strong computer skills in Adobe Suite, Microsoft Office, project management software and databases.
- Good problem-solving, organizational, analytical and critical thinking skills.
- Ability to work in a cross-functional environment while building positive internal/external working relationships.
- Good written and verbal communication skills.
Desired Qualifications- Extensive knowledge and efficient use of digital labeling design software platforms (e.g., Teklynx Central, Teklynx Codesoft, Adobe Creative Cloud, Illustrator, InDesign and Photoshop).
- Moderate knowledge of document management systems (e.g., EtQ Reliance).
- Ability to perform minor level tasks in SOLIDWORKS.
- Basic knowledge of FDA and global regulations as it relates to labeling requirements and documentation.
- Understanding of domestic and global labeling implementation.
Physical- Extended periods of computer use.
- Extended periods of sitting or standing or speaking.
- Light lifting, up to 25 lbs.
- May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs).
Salary Range$79,733 - $104,650 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)
