Regulatory Affairs Manager

The Regulatory Affairs Manager will provide direct regulatory support for screening products. This role will actively support development and implementation of regulatory strategies, premarket submissions, post-market change submissions, annual reports, labeling review, and other related activities. Responsibilities will include all aspects of product core team support, including planning and implementation of regulatory submission strategies, preparation of submissions, reviewing protocols and reports, and interpreting regulations and requirements. 

This position is an individual contributor role with expectations to be hands-on and will liaise closely with regulatory and cross-functional teams at Guardant Health to bring innovative diagnostic assays to market and keep them complaint.

Essential Duties and 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.

• 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.

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

The US base salary range for this full-time position is $104,900 to $141,600. The range does not include benefits, and if applicable, bonus, commission, or equity. The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role with the exception of any locations specifically referenced below (if any).

For positions based in Palo Alto, CA or Redwood City, CA, the base salary range for this full-time position is $131,100 to $177,000. The range does not include benefits, and if applicable, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]

Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

All your information will be kept confidential according to EEO guidelines.

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Please visit our career page at: http://www.guardanthealth.com/jobs/