Staff Labeling Specialist - Virginia, Virtual Address

Work Flexibility: Remote or Hybrid or Onsite

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 development and sustaining labeling projects from concept to completion
• Collaborate with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and Marketing, to ensure accurate and timely labeling updates
• Mentor and train junior labeling specialists on best practices and regulatory requirements
• Establish and drive deadlines to meet project deliverables
• Develop and maintain labeling content for medical devices in compliance with global regulations and standards, including FDA, EU MDR, and others
• Review and approve labeling artwork, ensuring alignment with regulatory requirements and company standards
• Stay current with labeling regulations and industry trends to provide guidance and recommendations to the organization
• Assist with writing and maintaining work instructions regarding the labeling process and procedures
• Participate in audits and inspections related to labeling 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 other related discipline
• 4+ years of experience in labeling in medical device, Biomed, Pharma, Department of Defense, or highly regulated industry
• Experience with application of domestic and international regulatory requirements; and standards and guidance pertaining to medical device labeling requirements, i.e., Code of Federal Regulations governing medical device labeling (e.g., FDA, EU MDR).
• Strong working knowledge of software technologies and authoring environments used for labeling, publishing, and document control (e.g., Adobe Creative Suite/Cloud, Creo/CAD Prisym, Jira, XML, 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.

Travel Percentage: 10%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.