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Regulatory Affairs Lead

Science

Science

Legal
Alameda, CA, USA
Posted on Saturday, June 24, 2023

Science is an early stage company developing technologies for a range of serious unmet medical needs. We are unafraid to take difficult technical risks, secure in the knowledge that with a clear understanding of what we are doing and with support from powerful modern tools, more progress is possible than might be immediately obvious. Regardless of role or team, the two most important factors we look for in a candidate are evidence of exceptional ability and the addition of positive energy to the group. As a small, very early stage team in a largely unstructured environment, the ability to independently orient yourself to the problems that need to be solved and then follow through is essential.

We are looking for a regulatory affairs lead to drive the development of regulatory strategies and interpretation of applicable guidance documents and standards related to active implantable medical devices, neural implants, and brain-computer interfaces.

Role & Responsibilities:

  • Collaborate with technical teams to prepare regulatory submissions and other interactions with regulators.
  • Support the technical teams to maximize the effectiveness of their communications with regulators.
  • Provide regulatory input and guidance on clinical use and trial strategies as well as critical decisions such as pathway choices or opportunities like Breakthrough Therapy or Humanitarian Device Exemption designations.

Key qualifications:

  • Bachelor’s degree or higher in engineering, science, medicine, or other related field.
  • 5+ years of regulatory affairs experience in medical devices including active implantable devices.
  • Experience with medical device quality standards and regulations relating to active implantable devices.
  • Experience working cross functionally to develop and implement regulatory strategies.

Preferred qualifications:

  • Advanced degree(s) in a technical field with research experience applicable to FDA Class 2 or Class 3 medical devices.
  • Successful history managing the FDA review process with substantial experience interacting directly with FDA.
  • Experience working directly in the brain-computer interface space or deep brain stimulation.
  • Recent familiarity with the latest FDA guidances and other applicable standards to brain-computer interfaces, retinal prosthesis, gene therapies, and/or cell therapies.

Salary/Pay Range:

For individuals hired to work in California, Science is required by law to include a reasonable estimate of the compensation range for this role. We determine your level based on your interview performance and make an offer based on geo-located salary bands. The base salary range for this full-time position is $100,000-$165,000 annually + equity + benefits. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Please keep in mind that the equity portion of the offer is not included in these numbers.

Benefits:

At Science, our benefits are in place to support the whole you:

  • Competitive salary and equity
  • Medical, dental, vision and life insurance
  • Flexible vacation and company-paid holidays
  • Healthy meals and snacks provided for non-remote employees
  • Paid parental, jury duty, bereavement, family care and medical leave
  • Dependent Care Flexible Spending Account, subsidized by Science
  • Flexible Spending Account
  • 401(k)

Science Corporation is an equal opportunity employer. We strive to create a supportive and inclusive workplace where contributions are valued and celebrated, and our employees thrive by being themselves and are inspired to do their best work.

We seek applicants of all backgrounds and identities, across race, color, ethnicity, national origin or ancestry, citizenship, religion, sex, sexual orientation, gender identity or expression, veteran status, marital status, pregnancy or parental status, or disability. Applicants will not be discriminated against based on these or other protected categories or social identities. Science will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state and local law.