Regulatory Affairs Intern

3 months ago(9/12/2017 3:05 PM)
Requisition ID
2017-2984
Job Location(s)
Bloomington IN United States
Shift Type
First
Position Type
Internship
Company
Cook Inc.
Category
Internships

Overview

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.

 

Responsibilities

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

 

Potential projects

  • Regulatory affairs knowledge database update, assessment, and proposed improvement plan
  • Gap analysis of EU technical files to the European Union Medical Deceive Regulations

Qualifications

• 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) 

 

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