Intern, Regulatory Affairs (Musculoskeletal - Ortho/Spine)

MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1500 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.

Intern Duties

Interns will work closely with MCRA experts and mentors to gain critical hands-on knowledge in Regulatory Affairs, Ortho/Spine.

Interns will work closely with MCRA experts and mentors to gain critical hands-on knowledge in Regulatory Affairs – Orthopedics & Spine. Interns will research a specific topic and complete a meaningful project presentation. Potential projects topics include:

• Internal Comparison Data: collate and analyze mechanical test data from prior 510(k)s to develop control data analyses for select device types
• Internal Deficiency Database: Update previous interns FDA deficiency database and look at way to operationalize the database through AI or different software to increase functionality.
• Trending and Market Analysis: Evaluate the trends in orthopedics & spine and emerging technologies in the field. Evaluate how the field is changing and the MCRA current client list in relation to the emerging trends in the field. Evaluate if there are other expertise or areas to target for future growth including other regions.

Skills and Qualifications:

• Currently pursuing Engineering
• Incoming Junior or Senior.
• Strong technical background in databases and researching.

Internship Program Details:

• Duration: 8 Weeks (June 2, 2025 – July 25, 2025).
• Hours: 25 hours per week, 5 hours per day (approx. 9:00am-3:00pm daily – specific schedules may vary).
• Location: DC-Based hybrid schedule
• A laptop and other required equipment will be provided.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, an IQVIA business, is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.