Job Summary

• Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer.
• Senior Regulatory Affairs Specialist will serve as a regulatory lead to develop and execute global regulatory strategies to support registration, approvals, and lifecycle compliance of assigned In Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) products.
• All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays.

Matching Summary

Salary

Primary Location Base Pay Range: $99,540 - $136,890; Other US Location(s) Base Pay Range: $94,010 - $129,285; Benefits: Not specified

Skills & Requirements

Key Requirements

• Advanced degree in life sciences/engineering/law/public health with 2+ years relevant experience, or Bachelor’s with 4+ years experience
• 3+ years cross-functional experience in regulatory and/or clinical development
• Strong working knowledge of IVD/CDx and/or medical device development processes
• Demonstrated experience preparing technical documentation for global submissions
• Proven ability to independently manage regulatory submissions

Work Rights