Principal Regulatory Affairs Specialist - IVD

Principal Regulatory Affairs Specialist - IVD

02 Nov 2022
California, Cypress, 90630 Cypress USA

Principal Regulatory Affairs Specialist - IVD

Our client is a rapidly growing multinational diagnostic organization that is expanding their local regulatory team.

With a recent acquisition and ongoing NPD projects the team is looking for an experienced Principal/Sr. Regulatory Specialist who can lead core-teams, communicate directly with notified bodies, and take point on regulatory submissions.

This role will be responsible for:

  • Leading regulatory submissions: 510(k)s, EU IVDR, and Canadian Licenses

  • Providing pre-market regulatory strategy to ensure regulatory requirements are incorporated and approved

  • Interacting with FDA staff and/or other regulatory agencies

  • Mentoring junior regulatory team members

In particular the team needs a candidate who has:

  • >5 years of experience in Regulatory Affairs

  • A Bachelor's degree in life sciences or a related discipline

  • Authorship of US 510(k) submissions

  • Experience working with diagnostics products (IVD) either in molecular or immunodiagnostics

If you would like to learn more about this role please send in your application as I will be contacting top applicants for phone screens

EOE Statement: Specialist Staffing Group 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, disability, or veteran status.

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