Guardant Health is hiring a
Senior Regulatory Affairs Manager

Summary

The Senior Regulatory Affairs Manager will provide direct regulatory support for screening products at Guardant Health, a precision oncology company. The role involves developing and implementing regulatory strategies, preparing submissions, reviewing protocols and reports, and maintaining registrations by ensuring regulatory compliance.

Requirements

• Bachelor’s or higher degree in life sciences, engineering or related field with at least 7 years work-related professional experience
• 5+ years experience in a medical device or IVD regulatory affairs role, preferably in molecular diagnostics

Responsibilities

• Support screening new product development and support and sustaining teams
• Prepare regulatory submission documents in adherence with applicable regulations for submission to U.S. government agencies
• Support regulatory activities throughout product lifecycle and maintain registrations by ensuring regulatory compliance
• Author, amend, and supplement new or existing submissions, annual reports, Q-submissions, premarket approvals (PMAs), etc
• Review product related documents (e.g., plans, protocols, reports) and product labeling including marketing materials
• Facilitate product approvals through effective communications and negotiations with regulatory agencies, and project teams
• Manage regulatory project workflow including prioritizing project deliverables and establishing timeframes for projects with cross-functional teams
• Oversee progress and completion of projects with project team members, ensuring timeframes and deadlines are met
• Lead and coordinate internal tracking, authoring, and review of responses to requests from regulatory agencies
• Identify project risk and develop alternate strategies or contingency plans as mitigation
• Provide strategic advice to the cross-functional team in response to their queries, based on regulatory experience and area of expertise
• Build and maintain a cooperative and respectful working environment. Be available as an internal resource for peers, advising on regulatory issues and strategies
• Participate in the planning and execution of the regulatory strategic direction for the business
• Provide updates to project teams and management regarding regulatory status and requirements of company products

Benefits

• Hybrid Work Model: At Guardant Health, employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays
• Competitive salary range: $98,300 to $157,300 (US base salary for full-time position), with potential adjustments based on work location and additional factors