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Intern, Regulatory Affairs in Marlborough, MA at Angiodynamics, Inc.

Date Posted: 3/5/2018

Job Snapshot

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Job Description

AngioDynamics provides benefits to patients by being the leader in design, development, manufacturing and marketing of innovative, proprietary, therapeutic devices used by interventionalists and surgeons for the minimally invasive treatment of peripheral vascular disease, tumor therapy and other, non-vascular diseases. Our summer internship program will give interns a project based learning experience that will strive to build your understanding of how a medical device business operates, enhance your skillset and grow your network. This internship will provide practical, professional experience for the college student while contributing to the overall goals of the Regulatory Affairs (RA) team.

The Regulatory Affairs intern will be a member of the Regulatory Affairs (RA) team. Regulatory Affairs is a profession within regulated industries, including pharmaceuticals, medical devices, and biologics, among many others. Regulatory professionals are tasked with a variety of responsibilities intended to ensure that their company complies with all of the regulations and laws pertaining to their business, both domestically and internationally. These responsibilities include advising the company on the regulatory aspects/climate that affect proposed activities, working with federal, state, and local agencies on a regular basis, and ultimately making products available worldwide. A regulatory professional’s responsibilities begin in the R&D phases, and extend through to manufacturing, clinical trials, labeling, advertising, and finally to post-market surveillance. The RA Intern will support and/or lead projects to support the overall RA team goals.

Position Responsibility:
  • Primary project lead for reviewing existing technical files/Design Dossiers and perform gap analysis for international submissions (drawings, raw materials, specifications and supplier agreements).
  • Assess, update, review and complete RA technical files.
  • Create a technical file index to establish the foundation for future department work.
  • Assist preparation and maintenance of regulatory international submissions.
  • Interface with in-country Regulatory Affairs.
  • Assist with organizing regulatory files (paper and electronic).
  • Work on projects that will help develop analytical, audit, and research skills.
  • Attend and participate in department meetings.
  • Use Excel, Word, Project Management, or Visio to create correspondence, spreadsheets, forms, graphs, flowcharts, etc.
  • Ensure compliance with all relevant quality and regulatory/legal requirements.
  • Other duties as assigned by the supervisor.