Philips
Intern - Regulatory Affairs - Plymouth. MN - Summer 2025
Philips, Minneapolis, Minnesota, United States, 55400
Job TitleIntern - Regulatory Affairs - Plymouth. MN - Summer 2025
Job Description
Intern - Regulatory Affairs- Minneapolis, MN - Summer 2025
We welcome individuals who are currently pursuing an undergraduate degree in engineering to join Philips as a Regulatory Affairs Intern in our Minneapolis location for a 3-month long internship to play a role in creating our next generation of healthcare solutions.
Your role
Join Philips Image Guided Therapy (IGT), 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.
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 regulationsYou 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 skillsMust be able to manage multiple tasks and perform with accuracy and a high attention to detailProficient 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 position.
Philips Transparency Details
The hourly pay range for this position is $25.00 to $28.00, 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 found here.
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.
Additional Information
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.
Company relocation benefits
will not
be provided for this position. For this position, you must reside in
or
within commuting distance to Plymouth, MN.
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.
Job Description
Intern - Regulatory Affairs- Minneapolis, MN - Summer 2025
We welcome individuals who are currently pursuing an undergraduate degree in engineering to join Philips as a Regulatory Affairs Intern in our Minneapolis location for a 3-month long internship to play a role in creating our next generation of healthcare solutions.
Your role
Join Philips Image Guided Therapy (IGT), 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.
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 regulationsYou 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 skillsMust be able to manage multiple tasks and perform with accuracy and a high attention to detailProficient 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 position.
Philips Transparency Details
The hourly pay range for this position is $25.00 to $28.00, 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 found here.
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.
Additional Information
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.
Company relocation benefits
will not
be provided for this position. For this position, you must reside in
or
within commuting distance to Plymouth, MN.
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.