Stellenbeschreibung:

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

The Senior Regulatory Affairs Specialist will  be responsible for supporting activities that 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. This individual will review and approve technical documents, and write/edit regulatory documentation to support regulatory submissions in EU, UK, LATAM, and other OUS regions.  
 

Essential Functions: 

• Support regulatory approval of NGS based IVD medical devices in global markets. 

• Manage Submission activities to align with Global regulations.  

• Prepare, compile, and publish electronic and hardcopy regulatory submissions consistent with applicable regulatory requirements/guidance. 

• Support complex CDx development projects with multiple pharmaceutical partners from early development to Health Authority submission. 

• Interact with multifunctional teams, regulatory colleagues and pharmaceutical partners to determine optimal regulatory paths towards development and registration activities. 

• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographies and disciplines as relevant to assigned projects. 

• Provide regulatory support on project teams. 

• Participate in review of labeling changes. 

• Review proposed device changes. 

 

• A minimum of BS degree, open to MS or Ph.D. in a scientific/engineering discipline. Advanced degree preferred. 

• A minimum of 4 years of experience in regulatory, development, clinical, quality or program management in the medical device or pharmaceutical industry is required, OR minimum of 3 years of relevant experience at an in-vitro diagnostic (IVD) manufacturer or related industry. 

• Regulatory experience required. 

• Strong understanding of global regulatory frameworks, with hands-on experience in LATAM and EU regions strongly preferred. 

• CDx or IVD device experience is strongly preferred 

• Demonstrated project management and organizational skills 

• Excellent writing and verbal communications skills 

• Self motivated and proactive work style 

• Ability to work in a fast-paced/entrepreneurial team environment 

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 $95,540 to $131,370. 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 $112,400 to $154,550. 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]

A background screening including criminal history is required for this role. GH will consider qualified applicants with criminal arrest or conviction histories in a manner consistent with applicable law including but not limited to the LA County Fair Chance Policies and the Fair Chance Act (Gov. Code Section 12952).

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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