Regulatory Affairs Co-Op/Intern

Nova Biomedical • Waltham, MA

91d

About The Position

Nova Biomedical is hiring a Regulatory Affairs Intern for the January 2026 Co-Op Cycle (January - July 2026) in our Waltham, MA facility. The RA Intern will provide pre-market and post-market regulatory support to US FDA, Health Canada, EU, and other International Regulatory Licensing and Registration Agencies.

Requirements

• Previous Regulatory experience preferred
• Previous Regulatory labeling review experience preferred
• Knowledge of ISO 13485, FDA QSR, IVDD/IVDR
• Excellent technical writing skills
• Quality System auditing experience is preferred
• Excellent communication skills
• Statistics and database management proficiency preferred
• MS Office experience
• BS Degree in Sciences or equivalent
• 0-3 years IVD or Medical Device experience, specializing in Quality or Regulatory Affairs

Nice To Haves

• MS in Regulatory Affairs preferred

Responsibilities

• Support Self-Certified and Notified Body Reviewed EU Documentation Preparation
• Support International Device Licensing and Registrations
• Support Product Development Teams for New Product Submission Requirements
• Review Product Labeling and assist in ECO process
• Participate in and support internal and external Quality System Audits
• Technical Writing

What This Job Offers

• Career Level: Intern
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree