Cook Medical Regulatory Affairs Intern in Bloomington, Indiana
Regulatory Affairs Intern
Bloomington IN United States
More information about this job
The Regulatory Affairs intern position is a 12-week paid internship located in Bloomington, Spencer, or Ellettsville Indiana. It is offered for a period extending from mid-May through mid-August (exact dates depend on school calendars.) This position includes 401(k) options, access to a fitness center, onsite cafeteria option, an assigned mentor, one-time housing stipend, capstone presentation, intern events, and more. All internships provide hands-on experience with meaningful projects in the Medical Device Manufacturing Industry.
First round consideration will be given to individuals who apply by October 20, 2017.
The Regulatory Affairs intern will focus on the importance of understanding the need for a structured feedback loop of information received from regulatory authorities via additional information request to regulatory specialist and engineering. This provides continual improvement of our regulatory submissions regarding how we present the information in our submissions and the engineering testing included in the submission.
Through the internship the intern will gain the following:
Understand the role of regulatory affairs in a medical device company
Understand the U.S. FDA submission process- focusing on 510(k) submissions, but a general understanding of all devices classes for the US
Understand the importance pf regulatory agency feedback
Specific Job Functions/ Duties
Categorize inquiries from regulatory authorizes while entering data into Sharepoint database
Test the data entries in the database
Determine the usefulness of the database
Provide suggested improvements to the data collected and feedback on how the database is functioning
Regulatory affairs knowledge database update, assessment, and proposed improvement plan
Gap analysis of EU technical files to the European Union Medical Deceive Regulations
• All candidates should have an interest in a career in the Life Sciences field, a willingness to take initiative, and an ability to work well with others
• Candidates should be students entering their Junior or Senior year the following fall semester or entering graduate school; candidates who graduate the spring semester before this internship are also eligible
• A minimum GPA of 3.0 is preferred
• All candidates must provide proof of enrollment (including pre-registration certification for the following fall) for consideration
• Multiple disciplines will be considered (e.g.Life Sciences, General Business, and Management)