Specialist, Product Complaints (Remote)
: Job Details :

Work Flexibility: RemoteSpecialist, Product Complaints - RemoteStryker is seeking a Specialist, Product Complaints to join our Trauma and Extremities business. In this role, you will coordinate and support technical and scientific regulatory activities while maintaining systems to trigger and log regulatory reportingWhat you will do:Key Areas of Responsibility:

• Regulatory review of product complaints to determine adverse event reportability
• Perform adverse event filings, including MDR and MIR reports
• Clarification of information provided during the Intake process to provide better clarity surrounding event descriptions.
• Perform CMC tasks by following up with initial reporters to obtain complete information
• Ensure complaints are classified correctly and that all supporting data for investigations are adequately collected and attached to the complaint file
• Communicate with Global RAQA on complaint investigation or recall instructions
• Provide correspondence to regulatory agencies and maintain compliance to regulations
• Assists in the development of regulatory procedures and SOPs

What you need:Required

• Bachelor's degree in Engineering, Science, or related degree;
• 0+ years' experience

Preferred:

• Master's degree in Regulatory Science
• Execution of basic regulatory items

$56,000 - $101,400 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.