Senior Regulatory Affairs Specialist (REMOTE)

Company: Guardant Health
Location: Palo Alto
Posted on: November 24, 2022

Job Description:

Company Description
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360 -, Guardant360 CDx and GuardantOMNI - tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.
Job Description
The Senior Regulatory Affairs Specialist is responsible for the support of a variety of regulatory affairs activities and projects with oversight from senior regulatory staff. This includes tasks and deliverables such as US and international product submissions, registration life cycle maintenance, registration file organization and other related activities.
Essential Duties and Responsibilities:

• Responsible for generating and delivering documentation for life cycle management and/or registration of products domestically and internationally.
• Coordinates assessment of product changes to capture any impact to existing or in-process product registrations and letters to file.
• Coordinates and documents regulatory risk determinations for clinical studies.
• Assist in submission activities for a variety of device regulatory approvals including the pre-submissions, Premarket approvals (PMAs), CE mark, IDE submission, Annual Reports, Export certificates, etc.
• Ability to work in a fast-paced environment and maintain a "focused urgency" as required by specific events
• Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors
• Work with senior regulatory staff to identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
• Assists in implementing department procedures and maintaining regulatory requirement matrices.
• Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
  Qualifications
  
  • Bachelor's education degree in life-sciences, engineering, public health, or equivalent.
  • A minimum of 4 years of experience in medical device or diagnostic regulatory affairs.
  • Familiar with regulatory issues and challenges associated with medical device development. RAC Certification is encouraged.
  • Knowledgeable in the aspects of regulatory strategy creation, design control, cGMP / Quality Systems.
  • Experience providing RA feedback to cross-functional project teams providing active and successful regulatory guidance and RA strategies.
  • Successful track record of securing and maintaining product approvals and registrations through application of strong communication and analytical skills
  • Understanding of molecular technologies and the impact on outcomes and diagnostic results.
  • Strong organizational skills, excellent oral and written communication skills.
  • Attention to details, ability to compile data, summarize results and handle multiple tasks to prioritize and schedule work to meet business needs.
  • Self started with ability to work independently with minimal supervision.
  • Hands-on, action-oriented, and able to implement effectively through his/her team.
  • Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency.
    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.
    Covid Vaccination Policy: Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant's COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws. An employee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters.
    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 Peopleteam@guardanthealth.com
    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/
    

Keywords: Guardant Health, Palo Alto , Senior Regulatory Affairs Specialist (REMOTE), Other , Palo Alto, California