Regulatory Affairs Internship~
Kalia Health (KH) is a health justice startup committed to improving reproductive health outcomes for conditions such as preeclampsia. Preeclampsia is the second leading cause of maternal mortalities in the US and worldwide and affects birthing people of color with greatest severity, despite the condition being straightforward to manage if detected early. Symptoms are subtle, often leaving expecting parents unaware of the developing complications unless they attend regular prenatal care checkups and receive quality care. Left undiagnosed, the condition becomes eclampsia, which leads to organ failure, seizure activity, and serious or fatal health effects for both parent and unborn child. The ongoing mortality from preeclampsia and eclampsia exemplify health disparities between high and low resources settings and due to racial injustice.
Diagnosis remains a challenge for two reasons: 1) Many birthing people are unable to access routine prenatal screenings due to a lack of transportation, hospital closures, a lack of medical infrastructure, and numerous socioeconomic factors that limit opportunities to seek care; and 2) The current diagnostic protocol for preeclampsia (elevated blood pressure and proteinuria) is not very specific to preeclampsia. Clinicians have informed us that they often find it challenging to accurately identify preeclampsia given clouding factors such as white coat syndrome (causing readings of elevated blood pressure) and other pregnancy complications, which are both challenging to distinguish from preeclampsia and also lead to protein in the urine.
Our mission is to improve reproductive health outcomes through a home-based early detection of complications like preeclampsia and eclampsia. KH is currently developing a prototype for the Kal-PDx, an early preeclampsia detection strip to increase individual awareness about developing complications and provide birthing people with the tools they need to take control of their health..
Internship Job Description:
The Regulatory Affairs Intern manages the regulatory issues associated with commercialization of medical devices. Kalia is offering an opportunity to students to learn about the regulation of healthcare and related products, including medical devices, and diagnostic products. This internship opportunity will provide the intern with robust projects based on a real business need. The following projects may be included during the internship.
*Intern will implement infrastructure and determine and develop required documentation for FDA compliance as relevant to the product design stage.
FDA Submission Documents
*Intern will prepare FDA submissions documents as needed.
*Intern will design clinical validation trials required for FDA approval.
*Intern will maintain a regulatory plan and timeline, which will be update to reflect new learnings and process changes.
*To be defined – based on experience and project interests as mutually selected with Kalia Health
Requirements and Qualifications:
*Current Bachelors of Science or Master’s Degree student in Regulatory Affairs (or equivalent formal training in ICH Common Technical Document (CTD) format) or Biomedical Engineering
*Demonstrates interest in FDA regulated environment as applies to medical device development for clinical trials.
*Interest in medical devices and diagnostic technologies preferred.
*Demonstrates interest in electronic database management and structured information storage (archiving).
*Must be a good written and oral communicator.
*Must have strong attention to detail and demonstrated personal or professional experience with orderly information cataloging and retrieval. Ability to work independently, establishing project milestones and reporting.
*Awareness of processes for working in a regulated field for information management (medical, legal or life sciences) preferred.
*Strong interpersonal skills, positive attitude, proactive approach to problem solving, reliable and outcome driven.
*Self-starter attitude that proactively proposes solutions and ideas.
*Excellent and timely communication skills.
Type and Timing of Internship:
Part Time, during Summer;Fall Semester
Approximate Start/End Dates:
Email resume to email@example.com.
Primary Contact Email: