Regulatory Labeling Coordinator
- Earth City, MO
- $65,000 per year
- Permanent
- Full-time
- Collaborate with Regulatory Affairs to assess and interpret changes in medical device labeling regulations (FDA, MDR, ISO, and other global standards).
- Assess the impact of new or updated regulatory requirements on existing product labeling artwork and independently manage assigned change requests to ensure timely revisions and ongoing compliance with the latest corporate standards.
- Independently manage the creation and update of product labels through the Change Control framework, ensuring accurate artwork development, timely routing, and seamless transfer to the manufacturing environment.
- Proactively scope artwork needs, retrieve essential information, and ensure all tasks are completed on time and with accuracy.
- Ensure clear and consistent communication of labeling timelines, requirements, and progress with stakeholders for new product development and line extension projects, ensuring alignment with redlined or change control requests and project milestones.
- Create and revise external artwork (e.g., boxes, IFUs, labels) and coordinate with the Supply Chain team to ensure accurate artwork files are provided to vendors. Verify vendor proofs against QRA-approved files for consistency and accuracy.
- Develop and validate HIBCC and GS1 UDI labels for site production needs.
- Maintain the GUDID database in compliance with FDA criteria, ensuring accurate and up-to-date labeling information for inventory and distribution support for proprietary products.
- 3+ years of relevant Regulatory Affairs/QA experience, preferably in the medical device industry with knowledge of medical device product labeling regulations for both domestic and international industry standards (FDA, ISO, MDR).
- Knowledge of international standards for labeling.
- 2+ years of GUDID database management highly desired (FDA Database for Medical Device tracking)
- Proficiency in Adobe Creative Suite (Illustrator, Photoshop, InDesign) and Microsoft Office Suite.
- Experience with label barcoding software (e.g., BarTender, EasyLabel, Autolabel) a plus.
Term Incentive Compensation Summary Plan (the Plan) document, beginning with the 2025
Plan Year, pro-rated based on date of hire, you will be eligible to participate in the Plan. Your
target annual cash incentive payout target will be 3% of your Base Salary, as in effect on
December 31st of the Plan Year, and is based on achievement of financial objectives that will
be set annually. Your target annual cash incentive payout is deemed earned only if you remain
employed with the Company on the date the payout is made.
Personal Paid Time-Off (PPT): You will be eligible for two weeks of Personal Paid Time
(PPT), prorated for the current calendar year. PPT is a mix of personal, sick and vacation days
combined into one bank of paid time off. PPT is tracked in hours and is accrued on a bi-weekly
basis throughout the calendar year.
Benefits: Eligibility to participate in all benefit programs available to full-time employees of
Young Innovations, including health, dental and vision insurance, disability and life insurance,
and a 401(k) savings plan. A summary document is included for your review. More detailed
information regarding these benefits will be given to you on your first day of employment.
Effective date is the 1st day of the month following your start date.Workplace TypeThis is a hybrid position in Earth City,MO.Application DeadlineThis position is anticipated to close on Sep 12, 2025.About ActalentActalent 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.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 due to a disability, please email for other accommodation options.