MCRA 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 1100 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.
Interns will work closely with MCRA experts and mentors to gain critical hands-on knowledge in the Regulatory Affairs space. Interns will research a specific topic and complete a meaningful project presentation.
Potential projects topics include:
- Develop a document capturing feedback/non-conformances we have seen on MDR submissions (across the entire technical documentation file, including CERs) that will be used:
- To identify trends among areas of the submission that can be organized by device type, risk class, and even Notified Body
- To capture the responses sent to the EU Notified Body addressing their feedback/non-conformances (and document what has been successful and what has not)
- As a training resource for associates when they build an MDR technical documentation file
- Develop an internal summary of international markets (outside EU and Japan to give MCRA regulatory (and other MCRA departments) an understanding of where MCRA has the capability to help and high-level requirements of these markets. Eventually, we would take this internal summary and tweak it for inclusion to the MCRA website
- As time allows, the intern would review our current MDR templates for improvements (based on the research performed in item 1 above) and create new templates based on recent guidance’s published by the EU
- Intern will gain a basic understanding of international medical device regulations from several major markets across different device types/technologies. The intern will have increased/improved skills related to research, technical writing, project management, and interpersonal communications in a real-world setting
Skills and Qualifications:
- Currently pursuing a Bachelors or graduate degree in Regulatory affairs, engineering (bioengineering, biomechanical, etc.), life sciences
- Minimum 3.0 cumulative GPA
- Ability to grasp new concepts quickly; well-organized and able to work independently
- Analytical with strong research skills
- Strong written and verbal communication skills
- Proficient in Microsoft Office Suite, including PowerPoint and Excel
Internship Program Details:
- Duration: 8 Weeks (June 5th - July 28th)
- Hours: 25 hours per week, 5 hours per day (approx. 9am-3pm daily – specific schedules may vary)
- Location: DC-based internship with hybrid in-office and remote schedule
- A laptop and other required equipment will be provided.
- Application Deadline: March 31, 2023
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, LLC 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.