Regulatory Affairs Intern

Department: Quality

Location: US-North Carolina-Raleigh

Compensation: $20.00 - $40.00 / hour

Description

• Role Summary The Regulatory Affairs & Post-Market Surveillance (PMS) Summer Intern will support the Regulatory Affairs team with regulatory compliance, post-market activities. This role provides hands-on exposure to global regulatory requirements, including the US, Canada, EU, and other international markets, as well as post-market surveillance processes and regulatory documentation. Working under the guidance of experienced regulatory professionals, the intern may own small project(s) from start to finish such as supporting regulatory process improvements, minor change activities, or exploring the use of AI to enhance work efficiency while gaining practical experience in a regulated medical device environment.
• Role Expectations
• Assist with Regulatory Affairs activities supporting medical device compliance across the US, EU, Canada, and other global markets.
• Support Post-Market Surveillance (PMS) activities, including the collection, review, trending, and analysis of post-market data
• Assist in the preparation, maintenance, and update of PMS documentation (e.g., PMS Plans, PMS Reports, PSURs)
• Shadow and partner with senior regulatory professional(s) to learn regulatory requirements, interpret regulations, and apply them to assigned projects
• Support ISO 13485 and MDSAP-related activities, including audit preparation and documentation reviews
• May own small project(s) from start to finish, such as supporting regulatory process improvements, SaMD minor change projects, or exploring tools (including AI-based solutions) to enhance regulatory efficiency
• Collaborate with cross-functional teams such as Quality, Clinical, R&D, and Product Management
• Perform all assigned tasks with a high level of accuracy, attention to detail, and professionalism.
• What We Are Looking For
• Education: Currently enrolled in an accredited college/university; Working towards a bachelor's or advanced degree in a science-related field, or Regulatory affairs
• Experience: Participation in student organizations and/or other leadership experience
• Skills: Skillful in computer applications and business tools such as e-mail, MS Word, Excel, and PowerPoint
• Communication: Proficient written and oral communication skills
• Teamwork: 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
• Exposure to Artificial Intelligence/Machine Learning based Software as Medical Device and 3D printing.
• 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 Raleigh office for 5 days

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Equal Opportunity Statement

Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.