Neurobit Health is seeking a motivated and detail-oriented candidate to join our team as a Regulatory Affairs Intern, who will actively contribute to the company's compliance with FDA regulations and facilitate the smooth execution of regulatory activities. As a Regulatory Affairs Intern, you will play a crucial role in supporting our company's compliance with FDA guidelines and ensuring regulatory excellence across our projects.

In this role, you will have the opportunity to work closely with our regulatory team, gaining hands-on experience in drafting, preparing, and reviewing FDA applications, submissions, and related documentation. You will assist in compiling and organizing the necessary documentation for FDA submissions, ensuring accuracy and completeness. Additionally, you will conduct research on FDA regulations, guidelines, and industry trends to support our compliance efforts and contribute to the development of effective regulatory strategies.

The ideal candidate will possess strong attention to detail, excellent communication skills, and a solid understanding of FDA regulations. If this sounds like you, please apply. We can’t wait to learn more about you!

We’re currently looking for someone to work as a part-time intern (no more than 20 hours a week) with the potential of becoming a full-time role if we feel it meets expectations and works well for everybody; both you and us. This is a hybrid position with all interns working with our office in New York.

Please note that we are unfortunately unable to offer visa sponsorship, however we are still accepting applications from international applicants who are currently eligible for STEM OPT extension.

Position Duties:

• Collaborate with the regulatory team to prepare and review FDA applications, submissions, and related documentation
• Assist in compiling, organizing, and maintaining accurate records of documentation required for FDA submissions
• Conduct thorough research on FDA regulations, guidelines, and industry trends to support compliance efforts
• Contribute to the development and implementation of effective strategies for FDA compliance and regulatory affairs
• Monitor and stay updated on FDA updates, announcements, and changes in regulations that may impact the company's operations
• Communicate and coordinate with cross-functional teams to ensure alignment and adherence to FDA requirements
• Assist in preparing reports, presentations, and summaries of FDA compliance and regulatory affairs activities
• Support the regulatory team in conducting internal audits and quality assurance activities to maintain compliance standards
• Stay informed about advancements in FDA regulations and provide recommendations for process improvements and efficiencies