Senior Associate, Regulatory Affairs

Job Summary

A company is looking for a Senior Associate, Regulatory Affairs- Human Factors.

Key Responsibilities

• Draft usability engineering files and conduct use-related risk analysis
• Develop and execute regulatory services, including submissions and strategy development
• Collaborate with other departments and complete additional projects as assigned

Qualifications

• Bachelor's degree or higher in a scientific, engineering, or regulatory discipline
• Experience with medical device development is required
• Preferred experience in medical device usability engineering, animal testing, or clinical testing
• Understanding of engineering and biological concepts for pre-clinical and clinical strategies
• Strong research and analytical skills with the ability to lead projects