Intern, Regulatory Affairs

4 weeks ago

Aliso Viejo, United States MicroVention Full time
Job Description

Are you interested in working for an organization that is making a difference in people's lives every day? We're a high-growth company, customer-focused with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what MicroVention® TERUMO has to offer.

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.
Qualifications

Required Qualifications
  • 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.
Additional Information
  • The primary work location for this position is Aliso Viejo, CA (company headquarters)
  • Candidates must be eligible to work in the U.S. and not require visa sponsorship.
  • Relocation may be available for qualified candidates.

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