Working Student, Regulatory Affairs

Hiring By - Biostaffic

 BioPharma

Germany

Job Highlights

Not Disclosed

Posted 4 months ago
Job details
Make a meaningful difference to patients around the world. Our University Programs are designed to help early-career professionals contribute to solutions that transform patient lives. We also believe in investing in the future of our talented people across the globe, including early career professionals seeking to explore and establish themselves within the medical device industry. We’ll provide you with the opportunity to thrive in a dynamic environment where you can make innovative contributions. As a working student with us, you’ll find motivation and inspiration in a culture that emphasizes passion for patients as you discover your own strengths.
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.
How you will make an impact:
  • Participate in key regulatory activities related to Edwards Lifesciences site in Germany.
  • Review and approve of promotional and non-promotional materials from cross-function teams.
  • Support local implementation of field safety corrective actions (review of FSN, and other support as applicable).
  • Ensure timely notification with Competent Authorities of Germany regarding a medical device post commercialization lifecycle (first marketing, cease of marketing, disruption in supply, etc...).
  • Assist in carrying out regulatory intelligence monitoring for specific topics and perform assessment.
  • Provide support on projects, according to the priorities of the service (Quality Charter, product launches, ...).
  • Request for clinical trial authorization as applicable.
  • Participate in the development/update and continuous improvement of processes related to regulatory activities.
What you will need:
  • University student of Biomedical Engineering/ Pharmaceutical or related.
  • Fluent English and German is a must.
  • Background knowledge of regulatory requirements in EU is a plus.
  • Interest in learning the regulatory landscape of EU and ability to expand on it.
  • Excellent attention to detail, strong organizational skills, ability to work with a structural approach.
  • Strong communication skills, ability to collaborate with team members and stakeholders.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Germany

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 18, 2024
Company Overview
Edwards Lifesciences
Edwards Lifesciences

Current Openings: 0

Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
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