Hybrid Regulatory Intern

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.
Requirements
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