Labeling Specialist (Hybrid)
Stryker
Work Flexibility: Hybrid
As the labeling specialist, you will collaborate with product subject matter experts to assess and gather content and be responsible for the execution of label format and content compilation using specialized software for Stryker’s Joint Replacement Division.
You will need to live within commuting distance of our Mahwah, NJ office. You will need to be in the office 2 days a week and can work from home on other days.
What you will do
Assists in the timely development and completion of labels and supporting documents.Oversees the electronic regulatory submission process.Provides recommendations for the development of formats and guidelines for documentation.Ensures effective planning and management of timelines for technical documents.Creates, reviews, and releases text that meets all medical, legal, and regulatory requirements for labeling medical products.Monitors changes in labeling regulations in the US and abroad.Reviews labeling change information to ensure it is supported by data and consistent with the application.Partners with hospital and healthcare facility staff in global markets to ensure labels are compliant with regulations, standards, and business requirements, with a focus on attention to detail, collaboration, and customer needs.What you need
Required Qualifications:
Bachelor’s degree requiredPreferred Qualifications:
1 year of experience in the development and completion of labels and supporting documents within a regulated industryKnowledge of compliance standards and regulations$56,000.00 - $101,400.00 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.
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