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

Philips

3mo ago

Applications are closed

Internship
Full-time
Summer Internship
Government & Politics
Colorado Springs

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.

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

Philips

There's always a way to make life better.

Science & Healthcare

Industry

10,001+

Employees

1891

Founded Year

Mission & Purpose

Philips is a global technology company that focuses on healthcare, consumer lifestyle, and lighting solutions. They are dedicated to improving people's lives through meaningful innovation and advanced technologies. Their ultimate mission is to make the world healthier and more sustainable by providing innovative healthcare solutions that enhance patient outcomes and enable better living. Additionally, Philips aims to enhance people's daily lives with their consumer products, ranging from home appliances to personal care items. Through their lighting solutions, they strive to create efficient and sustainable lighting experiences for individuals and communities, promoting energy conservation and environmental responsibility.