Nova Biomedical is hiring an Regulatory Affairs Intern for the January 2025 Co-Op Cycle (January - July 2025) in our Waltham, MA facility (hybrid schedule). 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 preferred
• Knowledge of ISO 13485, FDA QSR, IVDD/IVDR

Skills and Competencies:

• Excellent technical writing skills
• Quality System auditing experience is preferred
• Excellent communication skills
• Statistics and database management proficiency preferred
• MS Office experience

Experience/Education:

• BS Degree in Sciences or equivalent
• MS in Regulatory Affairs preferred
• 0-3 years IVD or Medical Device experience, specializing in Quality or Regulatory Affairs

At 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.