Compliance Manager

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 :

• Bachelors 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 $120530 to $165710. 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 $141800 to $194950. 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 to 

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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