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Job Title: Regulatory Affairs Intern Location: This position is based in our Campbell, California offices. This position is on-site. Imperative Care does not provide relocation or additional housing compensation for the summer internship. Why Imperative Care? Do you want to make a real impact on patients? Imperative Care is changing the way stroke is treated.As part of our team, you’d be developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do. What You’ll Do Partner with Imperative Care functional groups to efficiently deliver accurate, timely, and effective regulatory documents and deliverables related to technical requirements of the US Food and Drug Administration (FDA) and/or international regulatory agencies in line with company objectives, policies and procedures.
Become familiar with the design, manufacture, and the clinical use of the Imperative Care products.
Partner with R&D, Operations, Supply Chain, and Marketing to help establish project deliverables to meet FDA requirements and technical international standards.
Become familiar with US FDA regulatory requirements and international standards to assist with regulatory assessments of design and manufacturing changes.
Assist with preparing US FDA regulatory filings such as Letters-To-File, 510(k)s, IDE Supplements, IDE Periodic Reports, Pre-Submissions.
Understand and perform regulatory intelligence research related to the US FDA and/or international regulatory agencies.
What You’ll Bring
Minimum of 2 years of college-level coursework in scientific or engineering degree (Biology, Biochemistry, Chemistry, Bioengineering, Industrial Engineering, Material Engineering or Mechanical Engineering) & a cumulative GPA of 3.0 or higher
What You’ll Gain
Imperative Care provides an opportunity for students to work in the dynamic medical device industry and gain valuable hands-on experience focusing on honing their downstream marketing skills. Our internship program is designed to give interns foundational experience and exposure to a variety of roles and areas of focus to help prepare them for a career in MedTech. This program also offers ongoing networking, learning and professional development opportunities, mentorship from executive leadership, social activities, and peer-to-peer interaction.
Salary: $27/ hourly for 10 week internship
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