Intern, Regulatory Affairs

Position Overview

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 Terumo Neuro 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 Terumo Neuro 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 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.

Job Details

Job ID 13240BR

Aliso Viejo, California, USA

Salary Range:

$21.00/Hour - $29.00/Hour (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)

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Required Qualifications
Required Qualifications
• Working towards a Bachelors or Master's degree in Regulatory Affairs or related field.
• Demonstrates a working understanding of regulations.
• Excellent written, verbal and interpersonal communication and computer skills.
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.

EEO
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.