Specialist, Labeling Design

Terumo Neuro; Aliso Viejo (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Terumo Neuro is seeking a Specialist, Labeling Design to design and manage product labels, IFUs, implant cards and related documents for global markets. You will collaborate with cross-functional teams to implement labeling changes, ensure QMS and regulatory compliance, and coordinate with suppliers for outsourced printed materials.

The role requires 3+ years in FDA-regulated labeling environments, strong software skills (Teklynx, Adobe CC), and excellent attention to detail.

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.

Responsibilities

• 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 QMS, regulatory requirements and guidelines, SOPs 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.

Skills

Labeling design

Adobe Suite

Project management

Cross-functional teamwork

Attention to detail

Education

Bachelor's degree in related field

Tools

Teklynx Central

Teklynx Codesoft

Adobe Creative Cloud

Illustrator

InDesign

Photoshop

EtQ Reliance

SOLIDWORKS

Job description

14274BR

Job Description:

Design, 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:

1. Bachelor’s Degree in related field or equivalent experience.

2. Three (3) years of experience in a medical device or pharmaceutical FDA regulated environment producing technical documentation.

3. Three (3) years of experience in labeling and digital design software platforms, including labeling database management.

4. High level of attention to detail and sustained focus.

5. Project management skills and experience.

6. Strong computer skills in Adobe Suite, Microsoft Office, project management software and databases.

7. Good problem-solving, organizational, analytical and critical thinking skills.

8. Ability to work in a cross-functional environment while building positive internal/external working relationships.

9. Good written and verbal communication skills.

Desired Qualifications

1. Extensive knowledge and efficient use of digital labeling design software platforms (e.g., Teklynx Central, Teklynx Codesoft, Adobe Creative Cloud, Illustrator, InDesign and Photoshop).

2. Moderate knowledge of document management systems (e.g., EtQ Reliance).

3. Ability to perform minor level tasks in SOLIDWORKS.

4. Basic knowledge of FDA and global regulations as it relates to labeling requirements and documentation.

5. 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).

EEO

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

Posting Country:

US - United States

Title:

Specialist, Labeling Design

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.