Regulatory Affairs Co-Op/Intern

Nova Biomedical is hiring an

Regulatory Affairs Intern

for the

January 2025 Co-Op Cycle (January - July 2025)

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 PreparationSupport International Device Licensing and RegistrationsSupport Product Development Teams for New Product Submission RequirementsReview Product Labeling and assist in ECO processParticipate in and support internal and external Quality System AuditsTechnical WritingQualifications: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.

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