Philips Intern - Regulatory Affairs Plymouth MN Summer 

United States, Minnesota 

471463177

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 are the right fit if

• Working towards Bachelor’s degree in engineering, or preferably in Regulatory Affairs and/or a science related field.
• 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.
• Requires strong written, oral and interpersonal skills
• Must be able to manage multiple tasks and perform with accuracy and a high attention to detail
• Proficient computer skills 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