Intern, Regulatory Affairs jobs in United States
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MicroVention-Terumo · 15 hours ago

Intern, Regulatory Affairs

positionAliso Viejo, California, USA
timeInternship
remoteOnsite
seniorityIntern
money$21/hr - $29/hr

MicroVention-Terumo is a high-growth company focused on making a difference in people's lives through reliable and technologically advanced products. The Regulatory Affairs Intern will learn about the product development process from a regulatory perspective, execute regulatory strategies, and support business by obtaining regulatory approvals for products.

Health CareManufacturingMedicalNeuroscience
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Responsibilities

Familiarize with the design, manufacture, and the clinical use of the Terumo Neuro products
Perform specific regulatory tasks in support of a regulatory filing for new/modified product and any planned renewal of regulatory registrations (FDA, EU or Health Canada)
Partner and collaborate with R&D, Operations, Quality, Labeling, and Marketing to help establish project deliverables to support regulatory submissions
Shadow and/or partner with a senior regulatory professional(s) to learn and interpret regulations and implement them on the assigned project(s)Learn regulatory affairs competencies to ensure product registration lifecycle processes compliance
Performs other duties and responsibilities as assigned

Qualification

Regulatory AffairsAnalytical abilitiesMaster’s degreeTechnical document comprehensionComputer skillsPriority managementCommunication skillsInterpersonal skillsIndependent work

Required

Working toward Master's degree in Regulatory Affairs or related field
Demonstrates a working understanding of regulations
Excellent written, verbal and interpersonal communication and computer skills
Proven analytical abilities and ability to comprehend technical documents and concepts
Ability to work independently and manage multiple priorities effectively

Company

MicroVention-Terumo

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MicroVention is now Terumo Neuro.
dateFounded in 1997
location
Tustin, California, USA
people-size1001-5000 employees
web-link
http://microvention.com

Funding

Current Stage
Late Stage
Total Funding
$51.6M
Key Investors
Crosspoint Venture PartnersU.S. Venture PartnersAdvanced Technology Ventures
2006-02-28Acquired
2003-09-04Series D· $10M
2002-08-30Series D· $19M

Leadership Team

A
Amy L. Walters
Vice President, Global Clinical Research
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Rob Greene
Senior VP, R&D
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Company data provided by crunchbase