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Internship

Intern - Regulatory Affairs - Colorado Springs, CO - Summer 2024

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Philips

•

15d ago

🚀 Summer Internship

Colorado Springs

AI generated summary

  • You are pursuing a degree in engineering or regulatory affairs/science, with knowledge of medical device regulations, FDA law, and global standards. Strong communication, organization, attention to detail, and computer skills required.
  • You will support regulatory filings, review issues with management, learn global requirements, and ensure compliance with FDA, ISO, and other regulations.

Summer Internship

Government & Politics•Colorado Springs

Description

  • We welcome individuals who are currently pursuing an undergraduate degree in engineering to join Philips as a Regulatory Affairs Intern in our Colorado Springs location for a 3-month long internship to play a role in creating our next generation of healthcare solutions. You will have the opportunitie to join the Philips Image Guided Therapy (IGT) team, a medical device manufacturer offering healthcare solutions in the field of cardiovascular imaging and interventional hemodynamics. The Regulatory Affairs Intern performs specific regulatory tasks in support of a regulatory filing or department project with direct support from management or more senior regulatory affairs specialists.

Requirements

  • You are working towards a degree in engineering, or preferably in Regulatory Affairs and/or a science related field.
  • You have eneral knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards, including ISO14971, IEC 60601 and related particular standards.
  • You have strong written, oral, and interpersonal skills.
  • You are able to manage multiple tasks and perform with accuracy and a high attention to detail.
  • You are proficient in computer skills, especially in Microsoft Office.

Education requirements

Currently Studying

Area of Responsibilities

Government & Politics

Responsibilities

  • Preparing post-market submissions i.e. PMA annual reports, updating technical files, and similarly scoped updates/submissions.
  • Support more senior RA Specialists in the preparation of regulatory filings for new products, as well as post market changes and line extensions.
  • Reviews regulatory issues with RA Management.
  • Obtaining knowledge in global regulatory requirements.
  • Following Spectranetics Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP and all other applicable regulations.
  • Applying FDA, ISO, EU, and other applicable regional regulations

Details

Work type

Full time

Work mode

office

Location

Colorado Springs