Legal and Regulatory Intern

Posting Date 2 weeks ago(11/18/2022 10:28 AM)
Requisition ID
2022-11754
Job Location(s)
Vandergrift PA United States
Travel
Less than 10%
Position Type
Internship
Company
Cook Vandergrift
Category
Regulatory Affairs

Overview

The 2023 Cook Inc. Internship position is a 12-week paid internship located in Vandergrift, PA. 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, on-site 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.

Responsibilities

Focus:

This internship will focus on the essential functions of regulatory affairs and how this contributes to the distribution of Cook Vandergrift medical devices.

 

Objectives:

The intern will learn how regulatory affairs plans and prepares submissions for regulatory approvals and makes assessments for FDA 510k modifications.

 

Job Functions:

Evaluate EU MDR revised intended use and indications and perform assessment for FDA 510k modifications, then present assessment to CVI Regulatory Affairs department.

Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regions.

Must have effective communication skills and ability to work in a collaborative environment.

 

Potential Projects:

Evaluation of EU MDR revised intended use and indications and subsequent assessment for FDA 510k modifications. Intern will optimize CVI’s current 510k modification process.

 

Qualifications

- Candidates should be students entering their Junior or Senior years the following Fall Semester. Graduate students are also eligible 
- A minimum GPA of 3.0
- All candidates must provide proof of enrollment (including pre-registration certification for the following fall) for consideration
- Enrollment in Bachelor’s degree program with a concentration in biology, basic science, or related field.

- Good communication and inter-personal skills with the ability to communicate clearly and concisely in both spoken and written form.

- Microsoft Office and Adobe

 

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