Compliance Engineer

About this role

The Compliance Engineer at SharkNinja will oversee regulatory compliance and certification for new products, particularly in the medical device sector. This role involves collaboration with product developers to ensure adherence to regulatory requirements and effective risk management throughout the product lifecycle.

What you'll do

• Support certification activities for new product development projects.
• Prepare regulatory filings, including FDA 510(k) submissions.
• Define project needs and deliverables for product teams and regulatory partners.
• Conduct risk management activities in compliance with ISO 14971.
• Engage in usability engineering processes for home healthcare devices.
• Evaluate project risks and develop contingency plans.

What they're looking for

• Bachelor's degree in relevant technical field
• Knowledge of FDA and EU regulatory requirements
• Experience with risk management standards
• Understanding of usability engineering principles
• Familiarity with medical device guidelines
• Strong analytical skills
• Excellent communication abilities
• Certification from RAC is advantageous

Benefits

• Opportunity to work in a global product design company
• Collaborate with innovative teams
• Engagement in meaningful projects
• Continuous improvement culture
• Supportive work environment
• [unknown]