Labeling Specialist

Job Title: Labeling SpecialistJob Description

Oversee the labeling process for new and existing IVD and MD products. Interface with Marketing, Regulatory Affairs, Supply Chain Management, Engineering, Clinical, and Manufacturing in the labeling development and revision process to ensure the requested deliverables are correct and meet specifications. Develop and maintain the design and layout of product manuals, IFUs, packaging and labels. Incorporate redlined changes made to artwork drafts to create final drafts and source files. Clarify open questions and request missing information on redlined artwork. Assist labeling creators/reviewers based on a strong understanding of regulatory standards and guidelines for IVD and MD labeling/labels. Proofread and act as departmental quality control for product descriptions and labeling content. Create and revise BarTender barcode label PDF artwork and source files. Obtain the required labeling requirement approvals. Provide documentation for labeling change orders: PDF artwork redlines, PDF artwork final drafts, source files, summary of changes, and certificates of translation. Manage translation supplier projects, priorities, budget, and delivery timelines. Coordinate with outside suppliers as needed to facilitate the ordering, receipt, and implementation of new and revised labeling.

Hard Skills

medical device

BarTender

Adobe

Job Type

This is a contract position with a duration of 12 Month(s).

Work Site

This is a hybrid position requiring some days on-site in San Diego, California and some days remote.

Work Environment

Hybrid role, Team of 2, Comfortable working in a regulated environment

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.