Work Flexibility: Hybrid or Onsite
Fixed Term Contract until November 2027 (benefits included)
Develops and maintains labels for complex medical devices. Collaborates with product subject matter experts to gather and assess labeling content providing best practices and standardization across our global business. Executes label format and compiles content using specialized software. Audience for labels includes hospital and healthcare staff in global markets. Labels must comply with medical device regulations, standards, and business requirements. This role is specialized.
Essential Duties & Responsibilities
- Own and drive the best practices for label design across our division globally.
- Fully understand and be able to apply global labeling standards and regulations. Additionally, be able to coach and mentor others on the team in this area of expertise.
- Collaborate with product SMEs to assess and determine label requirements and content: Regulatory Affairs, Product Development, Product Safety Engineering, Packaging Engineers, Clinical Sciences, Marketing, Trade Compliance, etc.
- Use specialized labeling software to generate templates and enter label data, text, and graphics into label database for print-on-demand label system.
- Supports multiple business units across the division.
- Ensure barcodes pass verification testing.
- Use desktop publishing software to design labels produced by external suppliers.
- Design label formats for functional usability by healthcare staff according to requirements based on global markets.
- Support multiple concurrent, complex labeling projects for new products, mergers and acquisitions, and label maintenance
- Collaborates globally with Technical Publications functions to discover best practices, collaborate on how we can address an issue, gap or strategy. Reaches out often and contributes to process improvements that impact Technical Publications to more efficiently impact the organization to establish a baseline across Stryker.
- Successful release of complex instructional project (software, multiple divisions, product interdependence, multiple market requirements).
- Participate in new product label planning meetings and capture requirements using quality system planning documents.
- Select appropriate label materials for labels applied to packages and products in collaboration with packaging engineers.
- Drive and lead innovation and strategic initiative projects.
- May be the Division Process Owner for labeling.
- Solve complex problems by filtering, prioritizing, analyzing and validating complex and dynamic material.
- As needed, support label translation strategies that satisfy international labeling needs.
- As needed, own and drive any applicable NC/CAPAs to closure.
- Review labels for completeness and presentation including labels created by others.
- Contact external suppliers to resolve label output details.
- Manage labels in PLM/CMS system for controlled label releases and revision management.
- Manage work to meet project milestones.
- Inform project managers of relevant aspects of language translation and impact to label design.
- Initiate/assist with departmental continuous improvement endeavors.
- Collect and track data/metrics associated with projects.
- Provide reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirements.
- May assist with regulatory audits.
Education & Special Trainings
- Bachelor’s Degree
- 4 years medical device, pharmaceutical, other highly regulated industry relevant experience.
Qualifications & Experience
- Able to apply fundamental and advanced concepts, practices, and procedures related to labels.
- Experience with a rigorous change management process
- Detail oriented with the ability to manage multiple simultaneous projects.
- Strong organizational and time management practices
- Able to prioritize and work within schedules.
- Must be able to understand and apply advanced technology applied to technical area.
- Excellent problem solving and analytical ability.
- Interest in language translation and international communication
- Understanding of impact of language translation to format design
- Ability to work under pressure in a fast‐paced environment.
- Highly developed computer skills and able to quickly learn new software.
- Hands-on experience with database compilation labeling systems such as i.e., Prisym preferred.
- Experience with Adobe Illustrator and enterprise CMS system desirable.
- Experience with external service suppliers
- Experience with regulatory compliance for medical devices or pharmaceutical labeling.
#IJ
Travel Percentage: 10%
