Regulatory Affairs Intern

Regulatory Affairs Intern
Location: Holliston, MA → In-Person (must have reliable transportation)
Duration: May 12th – August 22nd, 2025 (Full-Time, 9 AM – 5 PM)
Compensation: Summer Stipend – ($2–4k based on time and performance)

About the Role:
NeuroSync is seeking a Regulatory Affairs Intern to support compliance and documentation efforts for medical devices, with potential involvement in additional regulatory clearances and product launches. This internship offers a hands-on opportunity to gain experience with FDA regulations, ISO standards, and compliance processes in a fast-paced med-tech environment.
You’ll play a key role in preparing regulatory submissions, maintaining documentation, and working cross-functionally with engineering, clinical, and quality teams. The ideal candidate is a fast learner, highly detail-oriented, and confident working independently in a dynamic, regulated space.

Key Responsibilities:
• Maintain and organize compliance and regulatory documentation for a Class II medical device
• Contribute to regulatory submissions (e.g., 510(k), general wellness justifications, and other pathways)
• Research and interpret regulatory requirements, and translate them into internal documentation and SOPs
• Prepare documentation for audits, inspections, and clearances
• Track regulatory correspondence, internal approvals, and submission timelines
• Collaborate with Engineering, Quality, and Clinical teams to ensure regulatory alignment across projects
• Support internal audits and compliance gap assessments
• Take initiative to identify risks or inefficiencies, propose solutions, and drive them forward with minimal oversight

Essential Skills & Qualifications:
- Strong interest in regulatory affairs, medical device compliance, healthcare policy and/or quality
- Excellent attention to detail and documentation skills
- Strong organizational and time-management skills with the ability to meet deadlines
- Familiarity with FDA medical device regulations and quality system standards such as ISO 13485 and FDA QSR
- Effective written and verbal communication skills
- Must have reliable personal transportation for on-site work in Holliston, MA

What You’ll Gain:
• Real-world experience supporting regulatory activities for a Class II medical device
• Exposure to FDA, ISO, and international compliance frameworks
• Hands-on work with submissions, audits, and technical documentation
• Mentorship and insight into how regulatory strategy supports innovation and patient safety in med-tech