Regulatory Affairs Intern

The Lancet

North America , USA

General

Ending On: 10 Jul 2019 13 days to go

Keyskills

Job Description

We are looking for Regulatory Affairs Intern

Education:

Employment: Full-Time

Requirements: Salary: Competitive
Location: San Diego , CA, United States
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JobId: 2596
Job Title: Regulatory Affairs Intern
Location: San Diego, CA
Category: Operations
Open Date: 2019-06-05T09:03:01Z Close Date: 2024-06-03T00:00:00Z

Description:

At ResMed (NYSE: RMD, ASX: RMD) we pioneer innovative solutions that treat and keep people out of the hospital, empowering them to live healthier, higher-quality lives. Our cloud-connected medical devices transform care for people with sleep apnea, COPD and other chronic diseases. Our comprehensive out-of-hospital software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice. By enabling better care, we improve quality of life, reduce the impact of chronic disease and lower costs for consumers and healthcare systems in more than 120 countries. To learn more, visit ResMed.com and follow @ResMed.

The Operations team partners closely with ResMed’s five business leaders to understand their needs then providing a variety of products and services to help them meet those needs including Customer and Technical Services, Global Quality Assurance and Regulatory Affairs, Supply Chain, manufacturing, logistics and distribution. Focused on enabling new product introduction and operating excellence, our team strives to improve time to market for new products and services, improve efficiencies in our cross-functional processes, and improve our supply chain through digitization and automation to increase value add to our customers.

Let's talk about the team and you:

The Regulatory Affairs Intern will be responsible for supporting the Regulatory Affairs team in daily tasks, projects, and submission support activities including:

  • Maintaining Regulatory trackers, department reporting metrics and spreadsheets
  • Following up and updating statuses for Regulatory submissions to Health Authorities in the Americas region, primarily Latin America
  • Creating supporting documentation for Regulatory submissions
  • Other administrative duties such as sorting, filing, copying, and obtaining necessary documentation (legalization, apostille, etc) for inclusion with regulatory submissions.

At the end of this internship, he or she will have a greater understanding of the Regulatory process required to obtain approval of medical device products within various countries in the Americas.

Let's talk about Qualifications and Experience:
  • Detail oriented and highly organized
  • Ability to handle multiple projects
  • Strong interpersonal communication skills
  • Strong technical writing skills
  • Recent grad or student seeking a bachelor’s or associates degree
  • Ability to be creative and resourceful
  • Spanish/Portuguese writing/reading preferred

Okay, so what’s next?

Joining ResMed is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. Our hope is that each day you’ll uncover a new reason to love what you do. If this sounds like the workplace for you, apply now!

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Please note: Unsolicited resumes from employment agencies or other third parties will not be considered. ResMed is an Equal Opportunity Employer â€" Minority/ Female/ Disability/ Veterans. ResMed participates in E-Verify. The Notice of E-Verify Participation and the Notice of Right to Work are available for your review. ResMed is a smoke-free workplace.

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