Regulatory Affairs (RA) Intern 

The Regulatory Affairs team is responsible for executing regulatory strategies, submissions, interactions with regulatory authorities, and supports business by obtaining regulatory approvals for MicroVention® TERUMO products.  

As a Regulatory Affairs Intern, you will learn the product development process through a regulatory perspective and the requirements of the various countries worldwide in order to get products into their markets. You will review elements of risk management, design control documents and scientific testing that support a registration. You will also gain access to design team dynamics, requirements and deliverables through shadowing; thereby allowing you to draw on your scientific or technical background to make regulatory assessments. Valuable analytical and critical thinking skills will be honed during your time with the regulatory group. 

Responsibilities:   

Familiarize with the design, manufacture, and the clinical use of the MicroVention 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.