Regulatory Affairs Specialist

About the Job

As the Regulatory Affairs Specialist, you will be at the heart of Visby’s mission to revolutionize infectious disease testing. You’ll navigate the complex FDA landscape to bring innovative molecular IVD products to market.  We’re looking for a sharp technical writer and proactive problem-solver who thrives in a collaborative, fast-paced environment. Having a background in molecular diagnostics or OTC devices is a plus. 

More About the Team

You will be part of a team of regulatory professionals and scientists that are dedicated to obtaining regulatory authorization/clearances for Visby’s IVD products.  You will work closely with and be guided by the Regulatory Affairs Management and will work cross functionally with clinical affairs, research and development, commercial, operations and quality to achieve shared business objectives.

Responsibilities:

Regulatory Submission and Strategy

• 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

Product Lifecycle & Labeling

• Lead the end-to-end product labeling process, from drafting technical text, to collaborating with graphic designers, 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.

Usability

• Partner on Human Factors activities, including assisting with defining usability requirements, creating Use-Related Risk Analyses (URRA), and determining critical tasks.

How You’ll Make an Impact

The Regulatory Affairs Specialist will make a positive contribution to obtaining timely regulatory authorizations for Visby’s IVD products in a timely fashion. The Specialist will work with a cross functional group of management, scientist, engineers, clinical affairs and quality to develop and execute regulatory strategy.  Supports Regulatory Affairs Management in achieving company goals related to regulatory affairs. 

How Your Position will impact product quality and achievement of the quality objectives

The Regulatory Specialist will play a pivotal role in obtaining regulatory authorizations and maintaining regulatory compliance. Ensuring that regulatory submissions are accurate and of high quality will ensure that the product performance criteria are established and supported. 

We’d Like You to Have

• A B.S. degree, preferably in molecular biology, biology, biomedical engineering, chemistry or a 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

It’s Great If You Have

• 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