Lead Specialist in Regulatory Affairs

1 week ago


San Diego, California, United States INVIVOSCRIBE INC Full time
Join Our Team

Invivoscribe is a premier organization committed to Precision Diagnostics aimed at improving lives. With over 25 years of expertise, we have been leaders in the global standardization of testing and providing access to innovative cancer therapies.

Located in the dynamic region of San Diego, California, our international reach enables us to deliver a comprehensive array of products and services. In partnership with key stakeholders, we create molecular assays, reagents, controls, and bioinformatics solutions utilized by clinical laboratories around the globe.

Our laboratory network offers internationally standardized molecular and flow cytometry panels that support drug development on a worldwide scale. We collaborate with pharmaceutical firms and regulatory bodies to develop companion diagnostics essential for the approval of new cancer therapies. Our accredited clinical laboratories concentrate on biomarkers that inform treatment choices, minimal residual disease (MRD) testing, patient stratification, and trial enrollment, all aimed at accelerating drug approvals in oncology.

If you have a passion for precision diagnostics, consider joining us.

Position: Lead Specialist in Regulatory Affairs

The role of Lead Specialist in Regulatory Affairs at Invivoscribe encompasses spearheading regulatory compliance initiatives to ensure the timely execution of submission projects and the upkeep of technical documentation files.

Key Responsibilities:

  • Drafting submissions to regulatory authorities including the FDA, NB, and ROW.
  • Assessing Design Control documentation.
  • Overseeing Technical Files.
  • Documenting adverse events as mandated.
  • Filing annual reports as required.
  • Offering regulatory advice within Project Core Teams.

Qualifications:

  • A minimum of a B.S. degree in a technical or scientific discipline, with no less than 5 years of experience in Regulatory Affairs (preferably within medical devices or pharmaceuticals).
  • A proven history of crafting successful registration submissions.
  • Expertise in Microsoft Office Suite (Word, Outlook, Excel, and PowerPoint) and a readiness to learn new software.

What We Provide:

  • Modern facilities in San Diego County, with some flexibility for remote work.
  • A diverse and inclusive workplace that promotes learning and development.
  • A well-stocked breakroom with refreshments to keep you energized.
  • Competitive salaries, bonus potential, stock options, comprehensive benefits, 401k with employer matching, and generous leave policies.

Invivoscribe is dedicated to Equal Opportunity Employment.



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