Hybrid Regulatory Intern in Massachusetts

The Regulatory Affairs Intern will support the Regulatory Affairs team in daily tasks, projects, and FDA submission activities including:

• Assist in drafting, organizing, and editing regulatory documents for
• 510(k) submissions.
• Coordinate workflow for regulatory document reviews (internal and
• external) within submission timelines.
• Coordinate with cross-functional teams such as clinical, research,
• marketing, and product design teams to compile regulatory submission
• documents.
• Assist in product labeling reviews to meet US labeling requirements.
• Research applicable US regulations, standards and, FDA guidance
• documents to define US regulatory strategies for product submissions.
• Adhere to Quality Management standards and processes as required.
• Perform other related duties and responsibilities, on occasion, as
• assigned.
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