During this internship, you will focus your work on two specific projects: (1) development of a process for gathering, assessing, and communicating matters of regulatory intelligence to relevant parties; (2) develop a standardized system to document the regulatory history (product documentation and regulator interactions) across the DEKA medical device portfolio. These projects will teach you about different regulatory processes, device-specific regulatory topics, and how regulatory strategy can be integrated into the medical device development process.
How you will make an impact as a Regulatory Affairs Intern: Develop a process for communicating regulatory intelligence to key DEKA personnel.Develop a company-wide system for documenting regulatory correspondence, developments and activities for a diverse array of medical devices.Work closely with other RA personnel to learn regulatory processes, strategy and developments across multiple medical device projects in a real-world environment.
To be successful in this role as a Regulatory Affairs Intern, you will need the following skills and experience:Currently enrolled in an accredited college/institution pursuing Bachelors of Science or Master’s Degree in an Engineering discipline, Regulatory Affairs or equivalent.Demonstrated interest in FDA regulated environment as applies to device development and clinical trials.Personal or professional experience with orderly information cataloging and retrieval.Strong written and oral communication skills.Strong attention to detail.Ability to work independently, establishing project milestones and reporting.Strong interpersonal skills, positive attitude, proactive approach to problem solving, reliable and outcome driven.
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
Additional Information:
*Applicants should be aware that short-term housing options in Manchester, NH are limited and that DEKA is not able to financially assist with housing.
Public transportation is available and routes/schedules can be found by visiting the Manchester Transit Authority website, www.mtabus.org.
Please be aware that we try to make sure that our internship opportunities are well defined and will provide a unique experience. We understand that most candidates would like to know if they have a placement as soon as possible, but at DEKA it takes more time than other companies at we review every application that is submitted. We will try to let you know as soon as we can, but encourage you to pursue other opportunities as well.
*A full time student is defined as being enrolled in a minimum of 12 credits per semester at an undergraduate program, or a minimum of 9 credits per semester for a graduate program.