RA Intern

Nova Biomedical Corporation • Waltham, MA

1d • $25 - $25 • Onsite

About The Position

The Regulatory Affairs Intern supports pre-market and post-market regulatory activities for IVD devices in the U.S., Canada, EU, and other international markets. This role assists with EU Technical Documentation (self-certified and Notified Body reviewed), international device licensing and registrations, regulatory requirements for new product development, and labeling reviews. The intern also assists in Engineering Change Order process, participates in internal and external quality system audits, and contributes to regulatory and technical writing. The position works cross-functionally with teams impacted by ISO 13485 and FDA QSR requirements, including Quality, R&D, Marketing, Technical Support, Technical Writing, and International Sales. Ideal candidates are pursuing or recently completed a BS in a scientific discipline, have strong communication and technical writing skills, and possess foundational knowledge of FDA QSR, ISO 13485, and IVDD/IVDR. Prior coursework, internships, or early experience in Regulatory or Quality within IVD or medical devices is preferred. If youre passionate about Regulatory Affairs and want to be part of a team that is shaping the future of life sciences, wed love to hear from you, apply today!

Requirements

• Knowledge of ISO 13485, FDA QSR, IVDD/IVDR.
• Must be able to use basic office equipment: computer, printer, copier, telephone, etc.
• Must be able to remain stationary for long periods of time
• The full list of physical requirements for this role is available upon request.

Nice To Haves

• Previous experience Regulatory experience preferred.
• Previous regulatory labeling review experience 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

Benefits

• Summer Intern programs including lunch and learns, networking, and professional and social development
• Enjoy our Company marketplaces for lunch and snacks in most of our offices and our company subsidized cafeteria in our Waltham, MA headquarters.
• Although interns and co-ops are not eligible for Nova's full-time benefits program, they are eligible to earn sick time and are able to enroll in certain voluntary benefits

What This Job Offers

• Career Level: Intern
• Number of Employees: 251-500 employees