Regulatory Affairs Intern

Title: Regulatory Affairs Intern

Location: Cambridge, MA or Remote (U.S.)

Duration: [10–12 weeks / Summer Internship]

Company Description

Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX, IAG, Starbloom) late clinical stage company translating scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility data that showed our therapy’s strong safety profile and a notable preservation of cognition and function in patients with mild-to-moderate Alzheimer’s. We completed enrollment in our pivotal study, HOPE, in June 2025 and expect to release topline data from the trial in summer 2026. We are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world who are impacted by neurodegenerative conditions. With our patented brain stimulation technology, we are committed to developing convenient, safe and effective neuroprotective therapies to improve brain health and well-being for all.

Summary of Role

Cognito Therapeutics is seeking a motivated Regulatory Affairs Intern to support regulatory strategy and execution across our medical device programs. This role offers hands-on exposure to regulatory processes in a fast-paced, clinical-stage environment focused on advancing innovative therapies for neurodegenerative diseases.

The intern will work closely with Regulatory, Clinical, Quality, and R&D teams to support regulatory submissions, documentation, and compliance activities. This is an excellent opportunity for students interested in gaining practical experience in FDA-regulated medical device development.

Roles & Responsibilities:

Regulatory Documentation & Submissions

• Support preparation and organization of regulatory submissions (e.g., IDE, 510(k), PMA supplements, and international filings). 
• Assist in compiling, reviewing, and formatting regulatory documents and supporting materials. 
• Help maintain submission timelines and track regulatory deliverables. 

Regulatory Strategy Support

• Conduct research on regulatory requirements, guidance documents, and standards (FDA, ISO, and international regulations). 
• Summarize regulatory pathways and requirements for new products or indications. 
• Support development of regulatory strategies for ongoing and future programs. 

Compliance & Quality Support

• Assist in maintaining regulatory documentation in alignment with design controls and quality system requirements. 
• Support audit readiness activities, including document organization and gap assessments. 
• Help ensure compliance with applicable regulations (e.g., FDA, ISO 13485). 

Cross-Functional Collaboration

• Partner with Clinical, Quality, Engineering, and Operations teams to gather information for regulatory activities. 
• Support alignment of regulatory requirements with product development and clinical programs. 

Regulatory Intelligence & Reporting

• Monitor and summarize updates to regulatory guidance, policies, and industry trends. 
• Prepare summaries and presentations for internal stakeholders.

Qualifications & Experience

Education

• Currently pursuing a Bachelor’s or Master’s degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, Public Health, or a related field. 

Skills & Experience

• Strong interest in regulatory affairs and medical device development. 
• Excellent attention to detail and organizational skills. 
• Strong written and verbal communication skills. 
• Ability to manage multiple tasks and meet deadlines. 
• Familiarity with FDA regulations or quality systems is a plus. 

To Apply

Our company is an Equal Employment Opportunity employer. Please contact Emily Ioapo at eioapo@cognitotx.com. Thank you for your interest.