Remote Senior Regulatory Affairs Manager

Summary

Join Guardant Health as a Senior Regulatory Affairs Manager to provide direct regulatory support for screening products and actively support development and implementation of regulatory strategies.

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
• Experience with PMA, sPMA, 510(k), Q-Submissions, IDE, BDD, and other related regulatory submissions
• Strong working knowledge of IVD and/or medical device development, design control, change control and cGMP / Quality Systems
• Demonstrated experience with effectively preparing and coordinating regulatory submissions
• Successful track record of securing and maintaining product approvals and registrations through application of strong communication and analytical skills
• Awareness of regulatory issues and challenges associated with diagnostic and/or medical device development
• Strong analytical skills and attention to detail
• Excellent communication skills (verbal and written) and ability to convey complex issues in a straightforward manner
• Outstanding organizational skills to balance activities for multiple projects
• Self-started with ability to work independently with minimal supervision
• Hands-on, action-oriented, and able to negotiate and collaborate effectively

Responsibilities

• Support screening new product development and support and sustaining teams
• Effectively 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
• Responsible for managing regulatory project workflow including prioritizing project deliverables and establishing timeframes for projects with cross-functional teams
• Responsible for overseeing 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