Medical Device Regulatory Affairs Internship

About our Company: Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than thirty six thousand trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. More than 1 million users trust Medidata's seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. Discover more at www.medidata.com .The Program:At Medidata, interns will have the opportunity to accelerate their careers by working closely with experienced professionals and gain valuable, hands-on, full-time work experience. By being a part of our global organization, interns have the opportunity to work alongside our talented and committed professionals helping them to build a strong foundation for achieving their career goals. For 12 weeks, beginning May 18, 2026, interns will have an opportunity to gain a deep understanding of what it means to be a Medidatian. United around a single goal of empowering smarter treatments and healthier people. Medidatians work in a culture of curiosity, innovation and fun. You will be contributing to the line of business with sustainable and meaningful work.Our Summer Internship program also includes instructor led training, guided mentorship, exposure to senior leadership and community service. In addition to individual and specific related responsibilities, each intern will participate in our Intern Innovation Lab. Assigned to cross-functional teams, interns will work closely to develop an innovative solution to a business problem currently facing Medidata. As they work diligently to present their final solutions to a panel of top Medidata leaders, we are confident that our interns will make a significant impact on our business.About the Team:Medidata Global Compliance and Strategy's (GCS) mission is to help its stakeholders successfully navigate and interpret the global regulatory landscape thereby enabling Medidata's clients to maximize the potential of the Medidata Cloud unified platform. The GCS team creates meaningful customer interactions through the application of a risk-based approach to continuously improving quality within the global regulatory landscape.Primary job responsibilities include but are not limited to documenting a quality management system for devices (e.g. ISO 13485), device submissions (510(k), CE Mark).Responsibilities:Required practical experience related to life sciences regulatory landscape and associated Quality Management Systems for Medical Devices.Strong familiarity and proven skills in the design and implementation of a Quality Management System related to Medical Devices; Software as a Medical Device preferred.Basic understanding of ISO 13485 and IEC 62304 standards, specifically how they apply to Software as a Medical Device (SaMD).Qualifications:Throughout the duration of the internship program, you must be currently enrolled at an accredited college or university pursuing a Master's degree in Regulatory Affairs, Regulatory Science or Biomedical EngineeringExperience with Quality Management Systems for medical devices and/or software as a medical deviceExperience with corrective and preventive action programsThe salary range posted below refers only to positions that will be physically based in New York As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location. Pay ranges for candidates in locations other than New York, may differ based on the local market data in that region.The base hourly pay range for this position is $28 an hour.Equal Employment Opportunity: In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Medidata are based on merit, qualifications and abilities. Medidata is committed to 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 medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age, 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. Applications will be accepted on an ongoing basis until the position is filled.#LI-TC#LI-HybridInclusion statementIn order to provide equal employment and advancement opportunities to all individuals, employment decisions at 3DS are based on merit, qualifications and abilities. 3DS is committed to 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 medical or common conditions related to pregnancy or childbirth), 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. 3DS will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state laws and local ordinances. We are committed to fair employment practices and will evaluate all candidates based on their qualifications, regardless of past arrest or conviction history.Salary Pay Transparency