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.

Qualifications:

Student seeking a Bachelors or Masters degree in regulatory affairs

Knowledge in US medical device regulations,21 CFR 820 Quality

System Regulation and standards

Knowledge in electromedical devices and software medical devices

Critical Skills and Abilities

Highly organized

Ability to handle multiple projects

Strong interpersonal communication skills

Strong technical writing skills

Strong English writing skills

Attention to detail

Expert in Microsoft Office (Word, Excel and PowerPoint