Regulatory Compliance – Quality Management System (QMS) Intern

Job Description

Regulatory Compliance – Quality Management System (QMS) Intern | Medidata

The Tone:
This is an internship at Medidata, located in Hybrid, New York, NY. Medidata builds digital solutions for clinical trials, empowering smarter treatments and healthier people through technological advancements and data-driven insights. This role is crucial for ensuring Medidata’s solutions comply with global regulatory standards, accelerating clinical breakthroughs and expediting therapies to market. The intern will contribute to maintaining and improving quality within the global regulatory environment.

The TL;DR
• Role: Internship
• Type: Full-time
• Location: Hybrid, New York, NY
• Pay: $28 hourly
• Team: Global Compliance and Strategy (GCS)
• Mission: This person assists stakeholders in navigating global regulatory landscapes and continuously improving quality within the regulatory environment for Medidata’s unified platform.
• Tech Stack: ISO 13485, IEC 62304

What You’ll Actually Do
• Document: Systematically document a Quality Management System (QMS) specifically tailored for medical devices, ensuring alignment with standards like ISO 13485.
• Assist: Provide support for various medical device submissions, including the preparation of 510(k) applications and CE Mark documentation.
• Apply: Utilize practical experience related to the life sciences regulatory landscape and associated Quality Management Systems for Medical Devices in daily tasks.
• Contribute: Help design and implement Quality Management Systems specifically related to Medical Devices, with a focus on Software as a Medical Device (SaMD).
• Demonstrate: Show a basic understanding of ISO 13485 and IEC 62304 standards, particularly as they apply to Software as a Medical Device (SaMD).

The Must-Haves
• Background: Currently enrolled in an accredited college or university pursuing a Master’s degree in Regulatory Affairs, Regulatory Science, or Biomedical Engineering throughout the internship.
• Experience: Possess experience with Quality Management Systems for medical devices and/or software as a medical device, along with experience in corrective and preventive action programs (CAPA).
• Skills: Understanding of ISO 13485 and IEC 62304 standards, ability to assist with 510(k) applications and CE Mark documentation, and knowledge of Quality Management Systems for Medical Devices.
• Bonus: Strong preference for experience with Software as a Medical Device (SaMD) in the context of QMS design and implementation.