Job Summary

A staffing agency has an open position for a Telecommute Principal Regulatory Affairs Specialist in Eden Prairie.

Candidates will be responsible for the following:

• Leading regulatory strategy for 510K submissions
• Authoring 510Ks submissions
• Managing gap analysis and risk assessments

Position Requirements Include:

• Option to work from home 2 days per week
• 5-10 years regulatory affairs experience with medical devices, to include 510K authorship
• Experience work with quality management systems
• Bachelors Degree in engineering or scientific field