Intern - Regulatory Affairs- Minneapolis, MN – Summer 2025We 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 roleJoin 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 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 position.
Philips Transparency DetailsThe 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 InformationUS 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.It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran
Full-time