Regulatory Affairs Specialist

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360®, Guardant360 CDx and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early-stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

(Position can be remote but requires travel to Redwood City and San Diego facilities around 10% per month) 

As a Regulatory Affairs Specialist, you will be responsible for supporting activities in the cancer screening division which lead to and maintain global regulatory approvals for In Vitro Diagnostic (IVD) devices. This involves participation in product development teams, providing regulatory guidance and ensuring compliance with applicable regulations, guidance, and standards. You will review and approve promotional materials and technical documents, and write/edit regulatory documentation to support regulatory submissions.

Essential Functions:

• Assist in submission activities/deliverables for a variety of device regulatory approvals including pre-submissions, PMAs, PMA supplements, 510(k)s, CE mark, IDEs, annual reports, etc.
• Prepare, compile, and publish electronic and hardcopy regulatory submissions consistent with applicable regulatory requirements/guidances.
• Write, review, and edit technical documents to support regulatory submissions.
• Provide regulatory support and guidance to existing and new cross-functional product core teams.
• Assist in review of promotional material, device changes, documentation, process improvements, etc. for accuracy, consistency, and compliance with applicable regulatory and technical standards.

• Bachelor’s degree in a science, engineering, or related technical field.
• Minimum of 2 years of regulatory affairs experience with IVDs/Medical Devices or equivalent is preferred.
• Experience working with development core teams in cross-functional team settings.
• Previous experience in quality, development or other related areas will be considered.

Knowledge, Skills and Abilities:

• Excellent organizational and attention to detail skills are required.
• Strong writing, editing, reviewing and analytical skills are necessary.
• Results/goal-oriented and able to successfully complete tasks and resolve issues.
• Proven and effective interpersonal communications skills with demonstrated ability to interact with internal customers in a positive, friendly, and professional manner.
• High degree of initiative with the ability to work independently with some supervision.
• Ability to manage multiple assignments and changing priorities.
• Ability to work in a fast-paced/entrepreneurial team environment.
• Proficient in Microsoft Office, especially Word and Excel for editing and tracking documents.

Guardant Health AMEA 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.

Please visit our career page at:  https://www.guardanthealthamea.com/