Job Description
Job Description
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. Other responsibilities include :
- 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
Qualifications :
Previous Regulatory experience preferred.Previous Regulatory labeling review experience preferredKnowledge of ISO 13485, FDA QSR, IVDD / IVDRSkills and Competencies :
Excellent technical writing skillsQuality System auditing experience is preferredExcellent communication skillsStatistics and database management proficiency preferredMS Office experienceExperience / Education :
BS Degree in Sciences or equivalentMS in Regulatory Affairs preferred0-3 years IVD or Medical Device experience, specializing in Quality or Regulatory AffairsAt Nova Biomedical, we practice our core values of mutual respect, honesty, and integrity throughout the company. With a strong sense of family in the workplace, we are proud that one third of all our employees have been with us for over 10 years.