Project briefs · Health & Life Sciences
Edwards Lifesciences · Summer 2027
Clinical & Regulatory Affairs Intern: a project built for this posting
At Edwards' Irvine headquarters, the intern gains hands-on clinical or regulatory experience by helping apply medical device regulations so new heart-valve and related products can reach the market. Projects are matched to the student's strengths and business needs, and the posting notes it is a pipeline requisition for anticipated roles.
- Company
- Edwards Lifesciences
- Posting title
- Clinical & Regulatory Internship, Summer 2027
- Location
- Irvine, CA
- Season
- Summer 2027
- Pay (as posted)
- $54,000 to $72,000 (California base pay range, annualized)
- Majors named
- Life Sciences, Biomedical Engineering, Engineering, Statistics, Economics, Nursing, Law (law school students)
Checked open on the employer's careers site on 2026-10-16. Read the full posting ↗
What this role is really testing
The project
Mock 510(k) Regulatory Summary Document
A professionally formatted mock FDA 510(k) regulatory summary for a simple, predicate-based medical device, such as a pulse oximeter, demonstrating the candidate's ability to organize technical information according to real regulatory structure. This directly mirrors the core work of a regulatory affairs intern: reading guidance documents, applying device regulations, and producing clear written deliverables that support product submissions.
- Read the FDA's publicly available 510(k) Summary guidance page and download one real cleared 510(k) summary from the FDA database (search 'pulse oximeter' in the 510(k) database) to use as a structural model, note the required sections: device description, intended use, substantial equivalence comparison, and performance testing summary.
- Draft your own mock 510(k) summary for a lightly fictionalized version of the same device class, writing each required section in plain but precise technical language, invent a device name and manufacturer, describe its indications for use, identify a real cleared predicate device by K-number, and write a 3–5 sentence comparison of technological characteristics and performance claims.
- Format the finished document as a clean, consistently styled PDF with a cover page, section headers matching FDA conventions, a predicate comparison table, and a one-paragraph conclusion stating why the device is substantially equivalent, the final artifact should be openable in one click and readable as a professional regulatory document.
Free account. Provieo walks you through it and turns it into a page with a link you can put on your application. This posting comes with you.
Questions
Do I need to know how to code?
No. For roles like this one, Provieo builds the project as a live case-study page: slides, tables and findings you fill in. You bring the thinking.
Where did this project come from?
Provieo read the Edwards Lifesciences posting and generated it on 2026-10-16. If you paste the same posting yourself you may get a different project, so two applicants don't show up with the same one.
Is Provieo connected to Edwards Lifesciences?
No. This is an independent project idea based on a public posting. It does not guarantee an interview.