Philips Intern - Regulatory Affairs Springs CO Summer 

United States, Colorado 

758243588

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 general 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.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this

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 improve the lives of others.

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If you’re 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 .

The hourly pay range for this position is $25.00 - $28.00. 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 found .

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

be provided for this position. For this position, you must reside in