Regulatory Affairs Intern

Shockwave Medical

Jan 29, 2024

Applications are closed

Internship
Full-time
Summer Internship
Healthcare
Santa Clara

Requirements

Undergraduate full-time student attending an accredited university with major emphasis in Engineering, Biocompatibility, or Regulatory Sciences
Relevant academic project, internship, or prior experience
Technical writing skills
High proficiency in Adobe and Microsoft Office, especially Excel and PowerPoint
Must have good verbal and written communication skills
High attention to detail and organizational skills
Operate as a team or independently with management guidance

Responsibilities

Learn the basics of medical device development, design, clinical use, and regulatory requirements for Shockwave Medical products.
Learn submissions structures and technical requirements.
Support Regulatory team in completing assigned documentation requirements for registrations and other regulatory activities.
Assist with regulatory intelligence assignments to research country-specific requirements.
Research competitor activity and create benchmarking reports for assessment.
Learn the basics of Document Control/Change Management and assist in revising procedures.
Other duties as assigned.

Shockwave Medical

Making waves for underserved patients with cardiovascular disease via novel technologies. ⚡🌊

Science & Healthcare

Industry

1001-5000

Employees

Mission & Purpose

Shockwave Medical is revolutionizing the interventional treatment of advanced cardiovascular disease by developing technology that targets calcified plaque. Inspired by 30-years of safety and efficacy in kidney stone treatment, our Intravascular Lithotripsy family of catheters delivers localized lithotripsy at the site of cardiovascular calcium that enables gentle balloon dilatation of calcified, stenotic arteries. IVL catheters use sonic pressure waves to preferentially impact hard tissue, disrupting calcium, while leaving soft tissue undisturbed. An integrated balloon catheter then dilates the calcified lesion at low-pressure, restoring blood flow.