Regulatory Affairs Post Market Intern

Werfen•Bedford, MA

About The Position

The purpose of the internship is to provide meaningful professional hands-on experience to students with leadership potential and proven academic performance. Werfen hires students majoring in Engineering and Life Sciences fields into this internship program based on business need. Ideal candidates will combine technical and business knowledge with analytical strength and creative problem-solving abilities.

Requirements

Currently pursuing B.S. in Regulatory Affairs, Life Sciences, Engineering, Finance, Business, or Marketing with a minimum of 2 college semesters complete.
Confidence in using Microsoft Word and Excel tools.
Ability to multitask.

Nice To Haves

Enthusiasm, motivation, initiative and ability to work within an interactive and energetic workplace.

Responsibilities

Perform entry level work of a routine nature requiring application of standard techniques, procedures and criteria in carrying out a sequence of related tasks.
Be involved in the day-to-day activities of the team, including aiding other departments as they relate to department projects.
Gain an in-depth knowledge of the product and its associated processes, particularly the process activities in-which they will be directly involved.
Assist in nearly all aspects of the workflow.
Assisting with regulatory decisions submissions for adverse events and authoring MDRs for FDA and Health Canada submission.
Assisting with correction and removal files and communications.
Other assignments related to RA/QA to support Werfen requirements and priorities.
Review process procedures, change orders, equipment specifications, validation plans, and reports.
Assistance in creating, reviewing and maintaining department files.
Summarizes findings by computer readouts, statistical summaries, graphs and other methods.