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

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

Regulatory Affairs Specialist

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