Specialist, Product Complaints (Remote)

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.

Specialist, Product Complaints – Remote

Stryker 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 reporting

What 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.

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.