Internship - Regulatory Affairs - Fall 2019
DEKA offers Internships for full time students* (must be at least 18 years of age). Internships last a minimum of 10 weeks, 12 preferred, and fall internships are to begin no later than September 23, 2019.
The Regulatory Affairs intern will provide support to the regulatory department to ensure maintenance and organization of regulatory files (electronic and paper) for proper tracking of information and archiving. The intern will learn current skills for file management in electronic systems.
Key Responsibilities:
- Audit and update of regulatory correspondence files/logs, and submission archives.
- Shadow RA personnel to learn device development process in a real-world environment.
- Participate in regulatory assessment review and preparation of submission related activities.
Education, Experience and Skills:
- Must be currently enrolled in an accredited college/institution pursuing Bachelor of Science or Master of Science in Regulatory Affairs or equivalent major area.
- Personal or professional experience with orderly information cataloging and retrieval.
- Demonstrated interest in FDA-regulated environment as applies to device development and clinical trials.
- Demonstrated interest in electronic database management and structured information storage (archiving).
- Must be a good written and oral communicator with 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.
- Awareness of processes for working in a regulated field for information management (banking, medical, legal or pharmaceutical) preferred.
- Interest in complex devices preferred.
Applicants should be aware that short-term housing options in Manchester, NH are limited and that DEKA is not able to assist with housing.
Public transportation is available and routes/schedules can be found by visiting the Manchester Transit Authority website, www.mtabus.org
*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.