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Regulatory Affairs Intern

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

Joining Nova Biomedical as a co-op or intern means stepping into a mission-driven organization where your work has real impact. You'll contribute to meaningful projects alongside engineers, scientists, manufacturing and business teams who value fresh perspectives and new ideas. We're committed to helping students grow through hands-on experience, mentorship, and the chance to explore how your academic skills translate into the real world.

At Nova, you won't just observe, you'll learn, build, problem-solve, and play an active role in advancing technologies that support global health. It's an opportunity to develop your career while contributing to innovations that truly matter.

At Nova Biomedical, we're not just building instruments, we're powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.

With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we're building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.

Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you'll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.

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 you're passionate about Regulatory Affairs and want to be part of a team that is shaping the future of life sciences, we'd love to hear from you, apply today!

What you'll do:

• 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

What we are looking for in you:

• Knowledge of ISO 13485, FDA QSR, IVDD/IVDR.
• Previous experience Regulatory experience preferred.
• Previous regulatory labeling review experience preferred.

Physical Requirements for this role include:

• 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.

Why work for Nova Biomedical:

• 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

Work Location: on-site in our Waltham facility 5 days/week (M-F)

Targeted Salary Range: $25/hour

Working Hours: 08:30 PM - 05:00 PM

Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.