Visby Medical

Regulatory Affairs Specialist

Visby Medical

full-time

Posted on:

Location Type: Hybrid

Location: San Jose • California • United States

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Salary

💰 $85,000 - $135,000 per year

About the role

  • Navigate the complex FDA landscape to bring innovative molecular IVD products to market
  • Coordinate, prepare, and manage complex regulatory submissions (FDA 510(k), De Novo, presubmissions)
  • Proactively identify and mitigate risks to regulatory timelines and plans
  • Draft and review clinical/non-clinical protocols and reports to ensure data integrity and compliance
  • Collaborate with cross functional teams to provide regulatory guidance throughout the product lifecycle process
  • Lead the end-to-end product labeling process, including drafting technical text and managing design controls
  • Own and manage the company's unique device identification (UDI) program
  • Review/approve promotional and advertising and labeling materials to ensure regulatory compliance and alignment
  • Partner on Human Factors activities, including defining usability requirements and conducting risk analyses

Requirements

  • A B.S. degree in molecular biology, biology, biomedical engineering, chemistry or related life science discipline
  • Working knowledge of industry consensus standards and FDA guidance
  • Strong technical writing with the ability to translate complex data into clear regulatory narratives
  • Team-player with the ability to collaborate across different levels within the organization
  • Experience with labeling, promotional/advertising material review, and human factors preferred
  • Experience with unique device identification (UDI) administration
  • Proactive approach, with high sense of urgency and results orientation
Benefits
  • Highly competitive health insurance through United Healthcare or Kaiser
  • Company-funded HSA option
  • Flexible paid time off
  • 10 company holidays
  • Many other contemporary benefits and perks
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory submissionsFDA 510(k)De Novoclinical protocolsnon-clinical protocolstechnical writinglabelingunique device identification (UDI)risk analysisdata integrity
Soft Skills
collaborationteam-playerproactive approachresults orientationcommunication
Certifications
B.S. degree in molecular biologyB.S. degree in biologyB.S. degree in biomedical engineeringB.S. degree in chemistry