Regulatory Intern

Job Title Regulatory Intern Job Description Intern - Regulatory Affairs- Minneapolis, MN – Summer 2023 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. 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 may contact 888-367-7223, option 5, for assistance. In this role, you have the opportunity to 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. You are responsible for 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 To succeed in this role, you should have the following skills and experience 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. In return, we offer you Sharpen your talents with new challenges in our dynamic organization. As a market-driven company, we’re used to listening to our customers & apply the same thinking to our employees. We offer a competitive salary, outstanding benefits and flexibility in a career with a positive and supportive atmosphere in which to develop your talents further. 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. Candidates need to live within the territory. How we work at Philips Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.  Our hybrid working model is defined in 3 ways: We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving. We embrace flexibility: Choosing where, when, and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams, and our customers on a case-by-case basis.  We want to be at our best: The way we work, and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips? Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you. Visit our careers website to explore what it’s like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions. Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace. Embrace the unexpected Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000 brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while transforming themselves personally and professionally. Working at Philips is more than a job. It’s an experience filled with unexpected moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you. 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 EEO Is The Law and Supplement Poster | Pay Transparency Nondiscrimination Statement