Job Summary

A clinical and scientific staffing company has an open position for a Remote Senior Clinical Regulatory Affairs Specialist.

Individual must be able to fulfill the following responsibilities:

• Review product changes for impact on regulatory filings worldwide
• Support QA in executing compliance activities involving audit findings
• Review and approve documents such as change orders and technical documents

Qualifications Include:

• University Degree and minimum of 4 years of relevant experience, or
• Advanced degree with a minimum of 2 years relevant experience
• Advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience
• Practical knowledge of project management
• Ability to work independently under limited supervision to determine and develop approach to solutions