Regulatory Affairs Specialist (CDx)

Regulatory Affairs Specialist (CDx)

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Job Description

As a Regulatory Affairs Specialist, you will be responsible for activities which lead to and maintain regulatory approvals for In Vitro Diagnostic (IVD) devices. In addition, you will be responsible for assessment of device changes for regulatory implications for companion diagnostics and for regulatory risk determinations to assess the use of the device in clinical trials.

• Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets.
• Assist in pre-submission activities to gain FDA’s feedback on study designs and other proposals
• Assist in submission activities for a variety of device regulatory approvals including the US Premarket approvals (PMAs), CE mark, IDE submission, Annual Reports, Export certificates, etc.
• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
• May assist in review of labeling changes.
• May assist as the internal regulatory consultant for on-market product issues.
• May assist in review of proposed device changes.

Qualifications

• B.S./B.A. in a science, engineering, or related technical field.
• A minimum of 2 years of experience in Regulatory Affairs function.
• 2 years’ experience in an FDA regulated industry, or equivalent is preferred.
• Experience working in a cross-functional team setting is preferred.

• Strong organizational skills and attention to detail required.
• Experience with Microsoft based applications and general knowledge of PC functions necessary.
• Ability to work in a fast-paced/entrepreneurial team environment.
• Results and goal oriented.

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.

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

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