Senior Regulatory Affairs Specialist, Remote Option

Job Description

The Senior Regulatory Affairs Specialistwill manage activities associated with the approval of Class III in-vitro diagnostic (IVD) medical devices. This individual will also be responsible for assessment of device changes for regulatory implications for CDxandregulatory risk determinations to assess the use of the device in clinical trials.

• Support regulatory approval of Next Generation Sequencing (NGS) based IVD medical devices in global markets
• Manage Pre-Submission activities to align with FDA on proposals to support PMA/sPMA approvals
• Participate in formal CDRH/CDER joint interactions, including teleconference or in-person meetings
• Facilitate and prepare a variety of device regulatory submissions aimed at approvals (PMA, CE mark, IDE submission, Annual Reports, Export certificates, etc.)
• Assess Significant Risk / Non-Significant Risk / IDE exempt studies for study risk determination
• Support complex CDx development projects with multiple pharmaceutical partners from early development to PMA 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 geographic and discipline as relevant to assigned projects
• Provide regulatory support on project teams
• Participate in review of labeling changes
• Review proposed device changes

Qualifications

• BS, MS or PhD in a scientific/engineering discipline. Advanced degree preferred
• At least 4 years of experience in the medical device, diagnostics, biopharmaceutical or another life sciences industry
• Regulatory experience required, preferably at least 2 years
• RAC certification is preferred
• CDx and/or IVD device experience strongly preferred
• Familiar with FDA, IVDD/IVDR, ICH regulations/guidelines
• 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

Employee may be required to lift routine office supplies up to 20 lbs 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 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

Please visit our career page at:

#LI-MR2