Sr. Specialist, Labeling Design

MicroVention

6d•$105,067 - $131,334

About The Position

Design, develop, and update global labeling documents to include product labels, instructions for use (IFUs), patient implant cards, specifications, and technical documentation. This role involves developing strategies for continuous improvement of the Labeling program and procedures, conducting investigations and troubleshooting for labeling non-conformances, and providing consultancy to other teams regarding labeling implementation processes. The specialist will design, develop, and implement changes to new and existing product labels and IFUs using labeling and design software, collaborating with request initiators to understand requirements and develop solutions. Ensuring compliance with QMS, regulatory requirements, SOPs, and work instructions is crucial. The role also requires coordination with suppliers for outsourced printed products and translated materials, leading corrective action implementation, and completing labeling initiatives by collaborating with functional groups. Additionally, the specialist will assign tasks, provide guidance and mentoring to the labeling group and contractors, communicate assignment completion dates, and meet timeline commitments with minimal supervision. Other responsibilities may be assigned.

Requirements

Bachelor’s degree in related field or equivalent combination of education and experience.
A minimum of five (5) years of experience in a medical device or pharmaceutical FDA regulated environment producing technical documentation and 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.
Excellent problem-solving, organizational, analytical, and critical thinking skills.
Ability to work in a cross-functional environment while building positive internal/external working relationships.
Excellent written and verbal communication skills.

Nice To Haves

Extensive knowledge and efficient use of Enterprise Label Management software (e.g., Teklynx Codesoft, Loftware Spectrum, PRISYM 360, etc.).
Extensive knowledge of Adobe Creative Suite (e.g., Illustrator, InDesign, Photoshop, etc.).
Moderate knowledge of Product Lifecycle Management software (e.g., Windchill, Agile, Teamcenter).
Ability to create CAD drawings and perform intermediate level tasks in SOLIDWORKS.
Knowledge of FDA and global regulations as it relates to labeling requirements and documentation.
Understanding of domestic and global labeling implementation.

Responsibilities

Develop strategies for continuous improvement of the Labeling program and procedures.
Conduct investigations and troubleshooting to address labeling non-conformances and document appropriately per the quality system.
Provide advice or consultancy to other teams with respect to labeling implementation processes.
Design, develop, and implement changes to new and existing product labels and instructions for use (IFUs) using labeling and design software.
Collaborate with labeling change request initiators to understand requirements, design solutions, timelines, and deliverables.
Develop standardized and optimized label templates and identify issues associated with design.
Ensure labeling compliance with quality management system (QMS), regulatory requirements and guidelines, standard operating procedures, and work instructions.
Effectively collaborate with cross-functional groups and stakeholders for successful implementation of labeling designs and changes.
Coordinate with suppliers and vendors for outsourced printed products and translated materials.
Conduct investigations, root cause analyses, and the development of corrective actions to address labeling non-conformances.
Lead activities to implement corrective actions.
Complete labeling initiatives by collaborating with individuals from functional groups and providing solutions to meet objectives.
Assign tasks and provide guidance, mentoring direction to the labeling group and contractors regarding labeling workflow, project status, and priorities.
Communicate anticipated assignment completion dates to affected coworkers.
Meet timeline commitments with minimal supervision.
Perform other responsibilities as assigned.