Report this job

---

What is the problem? *

Incorrect company
Incorrect location
Job is expired
Job may be a scam
Other

Job TitleIntern - Regulatory Affairs - Colorado Springs, CO - Summer 2024
Job Description

Job title:

We welcome individuals who are currently pursuing an undergraduate degree in engineering to join Philips as a Regulatory Affairs Internin 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.


Your role:

Under the supervision of the Regulatory Affairs (RA) Manager or a more senior Regulatory Affairs Specialist, a Regulatory Affairs Intern is responsible for:
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


You're the right fit if:

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.



About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose.If youre interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.


Philips Transparency Details

The hourly pay range for this position is $25.00 to $46.00, plus overtime eligible.The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

Details about our benefits can be foundhere.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
A

dditional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Company relocation benefits
will not
be provided for this position. For this position, you must reside in
or
within commuting distance to Colorado Springs, CO.

Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees with a sincerely held religious belief and/or disability impacting their ability to obtain the COVID vaccine can request a reasonable accommodation.

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You maycontact 888-367-7223, option 5, for assistance.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.


Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.