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Intern, Regulatory Affairs (Digital Health)

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MCRA

2mo ago

  • Internship
    Full-time
    Summer Internship
  • Research & Development
    Healthcare
  • Washington
  • Quick Apply
    13d left

AI generated summary

  • You should be a Junior or Senior in Biological Sciences or Engineering, with skills in PowerPoint, Excel, strong writing, analytics, and be comfortable giving presentations.
  • You will assist in task analysis and risk assessment for medical devices, develop use scenarios, and create templates based on IEC 62366 and FDA guidelines for usability studies.

Requirements

  • Currently pursuing any of the Biological Sciences or Engineering disciplines.
  • Incoming Junior, or Senior
  • Proficiency in PowerPoint and Excel, strong writing and analytical skills, comfortable with giving presentations.

Responsibilities

  • Interns will work closely with MCRA experts and mentors to gain critical hands-on knowledge in Regulatory Affairs, Digital Health.
  • Usability study design usually starts with a task analysis which breaks down the workflow of using a device into individual tasks and assess the potential use errors pertaining to each task along with the resulted harms from said use errors.
  • The process of task analysis should not be streamlined for devices with a dynamic or flexible workflow, such as software devices with various modalities and functions.
  • A streamlined task analysis and use scenarios do not appreciate the possibility of a dynamic workflow where user is able to go back and forth in interfaces and prioritize certain modality over others in actual use scenarios.
  • The use-related risks from the flexibility of the interface would be easily left out in the risk analysis.
  • In this project, we will experiment various ways of task analysis and use-related risk analysis to find the best presentation of use scenarios for medical devices with a flexible workflow.
  • The project will base on a case analysis of an SaMD (software as medical device), followed by an analysis of the applicability of the results to other types of devices.
  • The intern can expect to learn to do task analysis and use related risk analysis according to IEC 62366 and FDA 2016 guidance on usability engineering, and get hand on experience in developing use scenarios for a usability study.
  • The deliverable of the project will be templates for presenting the task analysis, use-related risk analysis, and use scenario for devices with complicated workflows.

FAQs

What is the duration of the internship?

The internship lasts for 8 weeks, from June 2, 2025, to July 25, 2025.

How many hours a week will the intern work?

The intern will work 25 hours per week, approximately 5 hours per day.

Is there a specific location requirement for the internship?

Yes, the internship is based in Washington, DC, and follows a hybrid schedule.

What skills are required for this internship?

Candidates should be pursuing a degree in Biological Sciences or Engineering, and they should have proficiency in PowerPoint and Excel, strong writing and analytical skills, and be comfortable with giving presentations.

Will interns receive training in regulatory affairs and usability analysis?

Yes, interns will work closely with experts to gain hands-on experience in task analysis and use-related risk analysis, specifically focusing on usability engineering.

Is there any equipment provided for the internship?

Yes, a laptop and other required equipment will be provided to the intern.

What type of projects will interns work on?

Interns will experiment with task analysis and use-related risk analysis for medical devices with flexible workflows, including a case analysis of a software as a medical device (SaMD).

Is this internship position paid?

The job description does not specify whether the internship is paid; you may need to inquire directly for details.

Are there opportunities for mentorship during the internship?

Yes, interns will work closely with MCRA experts and mentors to gain critical knowledge and skills in Regulatory Affairs and Digital Health.

Are there any qualifications regarding the academic level of candidates?

Yes, the internship is intended for incoming Juniors or Seniors currently pursuing a degree in Biological Sciences or Engineering.

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MCRA

Leading Global Full-Service Medical Device, Diagnostics & Biologics CRO & Integrated Consulting Advisory Firm.

Manufacturing & Electronics
Industry
51-200
Employees
2004
Founded Year

Mission & Purpose

MCRA is the leading global full-service medical device, diagnostics, and biologics CRO and consulting advisory firm. MCRA delivers to its client’s industry experience, integrating its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, due diligence and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, London, England, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and medical device cybersecurity. MCRA places particular emphasis on its expertise working with companies in all stages of development and throughout the technology life cycle by ushering technologies from the conceptual pre-clinical stage to market approval.