Product Labeling Specialist
STERIS · St Louis, MO · 1 mo ago
HybridFull-time
This is a hybrid role requiring onsite work at our St. Louis, MO facility 3 days per week. This position is not eligible for visa sponsorship or H1B transfer.
About the role
The Product Labeling Specialist is a multi-faceted position encompassing the development and maintenance of medical device product labeling, informational and instructional literature, packaging, internal document control, change control, process control, and implementation of required regulations and guidelines.
Responsibilities
- Demonstrate excellent understanding of STERIS products and product labeling requirements, including branding, regulations, specifications, and language requirements.
- Interface with R&D scientists, engineers, graphic designers, supervisors, project leaders, marketing, operations, vendors, and others to gather information for new or revised product labeling.
- Coordinate product labeling project tasks through creation, development, completion, and release to production via the engineering change process.
- Develop project supporting documentation, including scientific documentation, risk management documentation, and online matrix databases.
- Coordinate with graphic designers, engineers, and scientists to develop instructional literature and product labeling projects.
- Ensure and verify accuracy and completeness of documentation, including proofreading, design control, obtaining approvals, and releasing to operations.
- Initiate and set up project development and labeling review packets using engineering drawings, design files, visual references, and research.
- Assist in formulating packaging specifications (paper, packaging, printing, inks) in conjunction with engineering, scientific, and manufacturing teams.
- Assist supervisor with project management activities, such as determining department priorities, resource allocation, and schedule planning.
- Responsible for self-direction in scheduling workload and prioritizing projects.
- Participate on project teams and establish good working relationships within STERIS.
- Participate in refining current processes, troubleshooting problems, and documenting processes and results.
- Demonstrate excellent attention to detail, consistency, and standard practices regarding product labeling.
- Work with minimal supervision.
Requirements
- Bachelor’s degree or High School Diploma/GED.
- 3+ years of experience in writing or reviewing technical documents with an emphasis on medical device operator manuals and instructional literature (6+ years if holding a High School Diploma/GED).
- 5+ years of experience with electronic desktop publishing equipment and layout programs.
- 5+ years of product labeling experience, including color specifications, logo, branding, trademark usage, UDI, GHS, regulatory, DOT, market requirements, and shipping regulations.
- 5+ years of experience with graphic design and product labeling coordination (IFUs, package inserts, labels, cases, cartons, user manuals, wall charts, pamphlets).
- 5+ years of experience working with outside print vendors.
Preferred Qualifications
- Adobe Creative Suite experience.
Benefits
- Market-competitive pay.
- Extensive Paid Time Off (PTO) and 9 additional holidays.
- Comprehensive healthcare, dental, and vision benefits.
- Long/Short Term Disability coverage.
- 401(k) with company match.
- Maternity & Paternity Leave.
- Additional benefits/discounts (e.g., Pet Insurance).
- Tuition reimbursement and continued education programs.
- Opportunities for advancement in a stable, long-term career.
Pay
The pay range for this opportunity is $68,500 – $85,000, with eligibility for bonus participation. Minimum pay rates will comply with county/city minimums if higher than the range listed.