Staff Regulatory Compliance Specialist, Quality and Regulation

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary 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 commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

About the Role:

The Staff Regulatory Compliance Specialist plays an integral role on the Quality team leading the company's compliance activities with the FDA Quality System Regulation, ISO 13485, IVDR as well as CLIA, CAP and applicable state requirements. The Staff Regulatory Compliance Specialist works cross-functionally to lead quality compliance initiatives and identify and execute opportunities for continual improvement.

Essential Duties and Responsibilities:

• Lead efforts for monitoring new and changing regulations and standards 
• Responsible for conducting an impact evaluation and gap assessment for new/changing regulations and standards, and collaborating with designated subject matter experts
• Provide Leadership and Guidance of the inspection readiness program
• Ensuring completion of all required remediations for compliance to new/changing regulations/standards
• Responsible for implementation and maintenance of the inspection readiness program 
• Responsible for remediating identified quality/regulatory compliance gaps/lessons learned from ongoing audits  
• Execute special quality/regulatory projects as assigned
• Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.

Qualifications

Essential Qualifications:

• B.S. degree in a scientific  discipline
• 10+ years of experience in the Life Sciences Industry, preferably in IVD regulated environment
• Expert working knowledge of FDA QSR, ISO 13485, ISO 14971 regulations
• Experience in compliance with quality standards in a regulated Molecular laboratory preferred
• Certified ISO 13485 lead auditor preferred
• Strong verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
• Ability to work effectively in a team environment, lead and mentor others and build strong working relationships
• Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
• Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management

Preferred Qualifications:

• Proven attention to detail and accuracy
• Effective  leadership and organizational skills
• Experience with Microsoft Office suite and Internet for business use

Work Environment

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.

Additional Information

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.

Covid Vaccination Policy:  Guardant Health requires all employees to be fully vaccinated. We follow the CDC guidelines for the definition of “fully vaccinated”, meaning an employee is consider fully vaccinated against COVID-19 after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination, and necessary booster vaccines. In addition, fully vaccinated employees will be required to maintain their fully vaccinated status under this policy by obtaining, if applicable, any FDA-approve