Regulatory Compliance – Quality Management System (QMS) Intern

Job Description

About Medidata

Medidata is a leading innovator in digital solutions for clinical trials, empowering smarter treatments and healthier people. With 25 years of experience, Medidata has driven technological advancements across over thirty-six thousand trials and 11 million patients. The company offers unparalleled expertise, analytics-powered insights, and one of the industry’s largest clinical trial datasets. Trusted by over 1 million users, Medidata’s seamless, end-to-end platform helps improve patient experiences, accelerate clinical breakthroughs, and expedite therapies to market. Learn more at www.medidata.com.

The Medidata Summer Internship Program

Medidata’s internship program offers a unique opportunity for aspiring professionals to accelerate their careers. Interns will gain valuable, hands-on, full-time work experience by collaborating closely with experienced professionals within our global organization. The program fosters a culture of curiosity, innovation, and fun, uniting participants around the goal of empowering smarter treatments and healthier people. Interns will contribute meaningfully to a line of business through sustainable work.

• Program Duration: 12 weeks
• Start Date: May 18, 2026
• Program Highlights:
  • Instructor-led training
  • Guided mentorship
  • Exposure to senior leadership
  • Community service
  • Intern Innovation Lab: Interns are assigned to cross-functional teams to develop innovative solutions to current business challenges facing Medidata. These solutions are then presented to a panel of top Medidata leaders, providing interns with the opportunity to make a significant impact on the business.

About the Global Compliance and Strategy (GCS) Team

The Medidata Global Compliance and Strategy (GCS) team is dedicated to assisting its stakeholders in successfully navigating and interpreting the global regulatory landscape. This enables Medidata’s clients to maximize the potential of the Medidata Cloud unified platform. The GCS team cultivates meaningful customer interactions by applying a risk-based approach to continuously improve quality within the global regulatory environment.

Internship Role: Regulatory Compliance – Quality Management System (QMS)

Key Responsibilities Include:

• Documenting a Quality Management System (QMS) for medical devices, specifically aligning with standards such as ISO 13485.
• Assisting with medical device submissions, including 510(k) applications and CE Mark documentation.
• Applying practical experience related to the life sciences regulatory landscape and associated Quality Management Systems for Medical Devices.
• Contributing to the design and implementation of Quality Management Systems specifically related to Medical Devices, with a strong preference for experience with Software as a Medical Device (SaMD).
• Demonstrating a basic understanding of ISO 13485 and IEC 62304 standards, particularly how they apply to Software as a Medical Device (SaMD).

Qualifications

• Must be currently enrolled at an accredited college or university pursuing a Master’s degree in Regulatory Affairs, Regulatory Science, or Biomedical Engineering throughout the duration of the internship program.
• Possess experience with Quality Management Systems for medical devices and/or software as a medical device.
• Experience with corrective and preventive action programs (CAPA).

Salary Information (New York)

The base hourly pay for this internship position, when physically based in New York, is $28 an hour. Pay ranges for candidates in locations other than New York may differ based on the local market data in that region.

Equal Employment Opportunity & Inclusion

Medidata is committed to providing equal employment and advancement opportunities to all individuals. Employment decisions are based on merit, qualifications, and abilities. Medidata upholds a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or related medical conditions), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age (40 and above), disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. Medidata will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.