Job Summary

A staffing firm has a current position open for a Telecommute Principal Regulatory Affairs Specialist.

Must be able to:

• Leading regulatory strategy for 510K submissions
• Manage life cycle from development to commercialization
• Manage gap analysis and risk assessments

Qualifications Include:

• There is the 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