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Job Information
Stryker Staff Labeling Specialist (Remote) in Redmond, Washington
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)
Who we want:
Problem solvers: Curious-minded achievers who resolve complex problems where precedent may not have previously existed
Articulate communicators : Individuals with a natural ability to communicate complex concepts into easily understandable ideas both verbally and visually
Relationship builders: Team players who collaborate and drive consensus with internal stakeholders to create powerful outcomes.
What you will do:
Lead and strategize on new product labels for medical devices from concept to completion
Maintain medical device product labels in compliance with global regulations and standards, including FDA, EU MDR, and others.
Collaborate with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and Marketing, to ensure accurate and timely product label updates
Mentor and train junior labeling specialists on best practices and regulatory requirements
Establish and drive deadlines to meet project deliverables
Review and approve product label artwork, ensuring alignment with regulatory requirements and company standards
Stay current with product label regulations and industry trends to provide guidance and recommendations to the organization
Assist with writing and maintaining work instructions regarding the device label process and procedures
Participate in audits and inspections related to product label processes and documentation.
Assist with the design and maintenance of product drawings.
What you need:
Required:
Bachelor's degree in Engineering, Graphic Design, Life Sciences, Regulatory Affairs, or related discipline
4+ years of experience in designing and updating product labels for medical devices
Knowledge and understanding of domestic and global regulations and standards. (Code of Federal Regulations governing medical device labeling (e.g., FDA, EU MDR).)
Experience with Adobe Creative Suite/Cloud, Creo, CAD, Prisym, Jira, XML, or Windchill
Preferred
- Project management experience
$75,300.00 - $156,900.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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