Job Description

Essential Duties and Responsibilities:

• Training & Education

  • Design and deliver compliance training for Company personnel, including sales and marketing teams, business development, client services and medical affairs.
    - Educate staff on specific compliance risks related to diagnostics

• Policy and Program Management

  • Assist in the ongoing development, implementation, and maintenance of the compliance program tailored to oncology and screening diagnostics operations.
  • Draft and update SOPs and internal policies governing laboratory practices, promotion and sale of healthcare services, billing and reimbursement.
  • Support the quarterly Compliance committee meetings, record meeting minutes and agenda planning and follow up.

• Regulatory Compliance

  • Monitor and interpret healthcare laws, regulations, and industry guidance relevant to diagnostic laboratories, including:
    - Clinical Laboratory Improvement Amendments (CLIA)
    - Food and Drug Administration (FDA) regulations for Laboratory Developed Tests (LDTs) and IVDs
    - Anti-Kickback Statute, Stark Law, and Sunshine Act (as applicable)
    - Monitor and triage incoming inquiries through the Compliance portal and the anonymous hotline

• Other

  • Develop a keen awareness of risks associated with the marketing and sale of cancer diagnostic products to proactively address issues and identify opportunities for process improvements
  • Maintain current and accurate knowledge of existing and emerging trends, enforcement actions, industry best practices and laws and regulations regarding healthcare compliance and interactions with healthcare professionals
  • Assist with internal investigations, as required, to promote a culture of zero tolerance for non-compliance, with heightened focus on timely follow up on incoming inquiries and complaints

Qualifications

• Bachelor’s degree with a minimum of 5 years of experience in a compliance role in the medical devices or diagnostics industry
• Juris Doctorate preferred
• Working and robust knowledge of the clinical laboratory, diagnostic, and medical device industries and enforcement of associated local regulations
• Certification in Healthcare Fraud & Abuse Law Compliance preferred
• Strong research, analytical, and problem-solving skills
• Demonstrated ability to advise and collaborate with business leaders and key stakeholders on compliance issues, facilitating risk assessment and developing practical business solutions
• Training and presentation experience in various settings including live audience and video conferencing
• Excellent strategic and analytical skills with the ability to help business partners identify compliant solutions to novel issues
• Ability to articulate risk without being an “alarmist”
• Excellent verbal and written communication skills
• Knowledge of privacy laws (GDPR, HIPAA) a plus
• In-depth knowledge of U.S. healthcare regulations and diagnostic testing standards.
• Strong analytical and problem-solving capabilities.
• Proficiency in documenting processes and preparing audit-ready materials.
• Ability to work independently in a fast-paced, evolving regulatory environment.
• Detail-oriented, with a strong sense of accountability and discretion.

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.

The US base salary range for this full-time position is $120,530 to $165,710. 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 $141,800 to $194,950. 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.

* end of pay transparency*

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 toPeopleteam@guardanthealth.com

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.

To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our_ Privacy Notice for Job Applicants _.

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

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