Senior Regulatory Affairs Specialist - International

Company Description

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.

Job Description

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. 

Qualifications

• 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 

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 create