Align Technology · 17 hours ago
Regulatory Affairs Intern
Align Technology is a company focused on regulatory affairs for medical devices, and they are seeking a Regulatory Affairs Intern to support regulatory activities for product registrations and improvements. The intern will perform assigned regulatory tasks, partner with senior professionals, and may own small projects to enhance regulatory efficiency using AI.
HardwareHealth CareManufacturing
Responsibilities
Perform specific assigned regulatory tasks in support of US/EU/Canada regulatory filing and global regulatory assessments
Shadow and/or partner with a senior regulatory professional(s) to learn and interpret regulations and implement them on the assigned project(s)
May own a small project(s) from start to finish, such as exploring and developing a tool to enhance regulatory efficiency using AI, while gaining knowledge in global regulatory requirements and regulatory processes
Support ISO 13485 MDSAP regulatory chapters during the audit
Support Medical Device Technical Documentation maintenance per EU MDR requirements
Support regulatory processes improvement
Support SaMD minor change projects, including QMS requirements
Qualification
Required
Currently enrolled in an accredited college/university; Working towards a bachelor's or advanced degree in a science-related field, or Regulatory affairs
Participation in student organizations and/or other leadership experience
Skillful in computer applications and business tools such as e-mail, MS Word, Excel, and PowerPoint
Proficient written and oral communication skills
Ability to work within a cross-functional team from various backgrounds, and as an individual contributor in a fast-paced, dynamic, but often ambiguous workplace
Motivated and quick to learn new concepts and understand technical writing/regulations
Organized and detail-oriented
Minimum availability of 12 weeks
Must be available to work in the office for 5 days: San Jose, California
Preferred
Exposure to Artificial Intelligence/Machine Learning based Software as Medical Device and 3D printing
Company
Align Technology
Align Technology, Inc. designs, manufactures, and markets the invisalign system for treating malocclusion or the misalignment of teeth.
H1B Sponsorship
Align Technology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (75)
2024 (57)
2023 (49)
2022 (60)
2021 (66)
2020 (31)
Funding
Current Stage
Public CompanyTotal Funding
$136MKey Investors
QuestMark PartnersComdisco Ventures
2001-01-26IPO
2000-06-21Series D· $105M
1999-10-07Series Unknown· $26M
Leadership Team
Recent News
Morningstar.com
2025-12-29
2025-12-11
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