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 :
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- 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.
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