Regulatory Affairs Intern
USA IT development
Job description
Doyou want to join us in helping to fight the world’s most threatening diseasesand enabling access to care for more people around the world? At SiemensHealthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.
AtSiemens Healthineers, we offer you a flexible and dynamic environment withopportunities to go beyond your comfort zone in order to grow personally andprofessionally. Sound interesting? Then come and join our global team as RegulatoryAffairs Student Intern to assist withdigitization projects and regulatory affairs preparation activities for productlife cycle management, registrations, and audits.
Ourglobal team: We are a team of more than 68,000 highly dedicatedemployees across more than 70 countries passionately pushing the boundaries ofwhat’s possible in healthcare to help improve people’s lives around the world.As a leader in the industry, we aspire to create better outcomes and experiencesfor patients no matter where they live or what health issues they are facing.Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guidedtherapy and innovative cancer care, is crucial for clinical decision-making andtreatment pathways.
Ourculture: We are part of an incredible community of scientists,clinicians, developers, researchers, professionals, and skilled specialistspushing the boundaries of what’s possible, to improve people’s lives around theworld. We embrace a culture ofinclusivity in which the power and potential of every individual can beunleashed. We spark ideas that lead to positive impact and continued success.Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.
This is a rolewell suited for a highly motivated student looking to build their skill set andgain hands-on experience. As a Regulatory Affairs Student Intern, you will beresponsible for:
- Taking part in knowledge exchange with our RA team to improve and further develop our product registration documentation.
- Creating international registration support documents for In Vitro Diagnostics (IVD) medical devices, as needed
- Providing support with Smart quality projects (digital regulatory tools). This may include assisting with validation or migration of content.
- Assisting with MDSAP (Medical Device Single Audit Program) audit preparations for regulatory affairs.
- Assisting with European IVDR documentation updates for IVD medical devices
Thisposition may suit you best if you are familiar with what is below, and would like to developyour skills with Healthineers:
- You have good PC skills (MS Office software like Word, PowerPoint, Excel and Outlook)
- You have good time management skills.
- You work well both independently and as a team.
- You will be working with our digital tools and therefore you are willing to learn about and work with new software solutions.
- You have a willingness to learn more about IVD products and the regulatory requirements for placing them on the market in various countries and regions.
Required skills and education to have for thesuccess of this role:
- Currently enrolled in a bachelor’s or master’s degree program, majoring in Biotechnology, Biomedical, Biochemistry, Chemistry, or related field. (Rising junior or senior preferred)
- Minimum 3.0 GPA (preferred)
Start Date: Summer 2024
The pay range for this position is $27.70 - $39.10 hourly; however, base pay offered may vary depending on education, skills, and experience. Siemens Healthineers offers interns paid time off.
At SiemensHealthineers, we value those who dedicate their energy and passion to a greatercause. Our people make us unique as an employer in the med-tech industry. Whatunites and motivates our global team is the inspiration of our commonpurpose: To innovate for healthcare,building on our remarkable legacy of pioneering ideas that translate into evenbetter healthcare products and services. We recognize that taking ownership ofour work allows both us and the company to grow. We offer you a flexible anddynamic environment and the space to move beyond your comfort zone to grow bothpersonally and professionally.
Ifyou want to join us in transforming the way healthcare is delivered, visit ourcareer site at https://jobs.siemens-healthineers.com/careers
If you wishto find out more about the specific division before applying, please visit: https://usa.healthcare.siemens.com/about.
Bewareof Job Scams
Please bewareof potentially fraudulent job postings or suspicious recruiting activity bypersons that are currently posing as Siemen Healthineers recruiters/employees.These scammers may attempt to collect your confidential personal or financialinformation. If you are concerned that an offer of employment with SiemensHealthineers might be a scam or that the recruiter is not legitimate, pleaseverify by searching for the posting on the Career site: https://jobs.siemens-healthineers.com/careers
“Successful candidate must be able to work with controlled technologyin accordance with US export control law.” “It is Siemens Healthineers’ policyto comply fully and completely with all United States export control laws andregulations, including those implemented by the Department of Commerce throughthe Export Administration Regulations (EAR), by the Department of State throughthe International Traffic in Arms Regulations (ITAR), and by the TreasuryDepartment through the Office of Foreign Assets Control (OFAC) sanctionsregulations.”
As an equal-opportunityemployer we are happy to consider applications from individuals withdisabilities.
Legal authorization to work in the U.S. is required. We willnot sponsor individuals for employment visas, now or in the future, for thisjob.
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.
California Privacy Notice
California residents have the right to receive additional notices about their personal information. To learn more, click here.