Job Description

Job Description

Job Description

Innovate, Empower, Grow—With Advanced Instruments

For nearly 70 years, Advanced Instruments has been at the forefront of innovation, helping organizations enhance quality, achieve reliable outcomes, and boost productivity in the biopharmaceutical, clinical, and food & beverage industries. We don’t just develop cutting-edge technology—we empower our customers with solutions that drive efficiency, precision, and performance.

From Solentim®, revolutionizing cell and gene therapy with advanced imaging and single-cell deposition, to OsmoTECH® and OsmoPRO® micro-osmometers, delivering accurate and reliable lab results worldwide, we set the standard for quality and reliability. Our Artel portfolio ensures precision in liquid handling through advanced validation, automation, and calibration tools. What sets us apart? With customer-centricity at our core, we take ownership, push boundaries, and collaborate to make a meaningful impact. Headquartered in Norwood, MA, with locations in UK and Westbrook, ME, our 340 employees worldwide are driving exciting growth this year.

???? Our Mission: To drive innovation that optimizes processes, increases efficiency, and delivers confidence in results.
???? Our Vision: To improve patient health through innovation and excellence.

If you're looking for a career where ingenuity, accountability, and collaboration fuel success, join us and be part of a team that’s shaping the future of our industry.

We are seeking a self- motivated, detail-oriented, and collaborative Regulatory Affairs Intern to work in a hybrid setting in our Norwood office to serve as a core team member of the growing regulatory affairs team.

A Day in the Life:

As a Regulatory Affairs Intern you will be responsible for supporting all regulatory activities within Advanced Instruments across three sites and multiple product lines. This includes supporting the registration of products and ensuring compliance with global regulatory requirements. The role requires collaboration with product management, quality assurance, R&D, commercial, and other teams to support the organization's goals. You will have the chance to assist in the preparation of global regulatory submissions (e.g. EU Technical Documentation, international registrations, etc.) to ensure timely approvals of new products. Also, you will support maintenance of product registrations and licenses, ensuring accuracy and compliance with all regulatory requirements (US FDA, Authorized Representatives, Notified Bodies, etc.).

What we are looking for in you:

• Bachelor’s or master’s degree in science or engineering (or working towards stated degree).

• Well-versed in Office 365 applications, including Word, PowerPoint, and Visio.

• Interest and aptitude to work in Regulatory Affairs; previous regulatory experience a plus.

• Strong organizational, written and verbal communication skills.

• Previous experience with IVDD/IVDR, MDSAP, and international registrations (Canada, Brazil, Japan, EU, Australia, APAC) a plus.

• Advanced degree/certificates in Quality/Regulatory a plus.

• Proficient in use of office equipment: computer, copier, phone; and software: Adobe, MS Word, Excel, ERP etc.

• Must be able to remain stationary for extended periods of time.

• Previous medical device and/or IVD industry background preferred; similar experience a plus.

Work Location: Norwood, Massachusetts (Hybrid)

What's in it for you?

• Flexible Medical, Dental, & Vision Coverage

• Competitive 401k company match

• Bonus Program, Generous PTO and paid holidays

• Generous Tuition reimbursement

• Hybrid and flexible work arrangements

• Professional development, engagement and events

• Company marketplace for lunch and snacks!

EEO Statement:

Advanced Instruments 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, Advanced Instruments 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 identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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