Job Description

Job Description Job Description Work Location : Sunnyvale, CA Hourly Pay Range: $20-$30/hour Job Type: Full-Time Onsite Our Company Founded in 2010, iHealth Labs is dedicated to empowering people to live healthier lives. The company is a leading provider of cloud-connected medical devices, personal health care devices, and home-based tests and is at the forefront of the digital health revolution. In November 2021, iHealth's COVID-19 Antigen Rapid Test received Emergency Use Authorization from the U.S. Food and Drug Administration for over-the-counter sales. Since then, iHealth has become a key supplier of at-home COVID tests to the federal government, state governments, nonprofits, and individual consumers. iHealth Labs is a leader in digital health solutions, with a mission to revolutionize the healthcare industry by making quality health management accessible and affordable for all. Summary We are seeking a motivated and detail-oriented Regulatory Affairs Intern to join our team. This internship provides hands-on experience in regulatory affairs for medical devices, supporting U.S. FDA requirements. You will assist in the preparation of regulatory documentation, maintain regulatory databases, and contribute to ongoing compliance efforts under the guidance of experienced regulatory professionals. Essential Duties and Responsibilities: Assist in preparing and organizing regulatory submission documents, including FDA Emergency Use Authorizations (EUA) and 510(k) premarket notifications. Support the review and formatting of product labeling and marketing materials for regulatory compliance. Help update and maintain FDA Establishment Registration, Device Listings, and GUDID (Global Unique Device Identification Database). Participate in reviewing protocols and study reports related to regulatory submissions. Assist in research and tracking of regulatory updates, guidances, and requirements applicable to iHealth’s product portfolio. Support the Regulatory Affairs team in internal audits, documentation tracking, and maintaining records in the Quality Management System (QMS). Collaborate with cross-functional teams to support project timelines and compliance goals. Perform other administrative and regulatory support tasks as assigned. Qualifications: Currently pursuing a Bachelor’s or Master’s degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, Public Health, or a related field. Strong interest in FDA regulations and medical device compliance. Excellent attention to detail, organization, and communication skills. Proficiency with Microsoft Office (Word, Excel, PowerPoint); experience with document control systems is a plus. Ability to work independently and in a team environment. Equal Opportunity Statement iHealth Labs is committed to diversity in its workforce and is proud to be an equal opportunity employer. iHealth Labs considers qualified applicants without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, marital status, pregnancy, sex, gender expression or identity, sexual orientation, citizenship, or any other legally protected class. iHealthLabs is an Affirmative Action and Equal Opportunity Employer. Please reference below for more information: -06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf and

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Hourly pay, Full time,

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