Edwards Lifesciences

Clinical & Regulatory Internship

Edwards Lifesciences

Irvine, CA, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Attention all aspiring clinical and regulatory professionals! Are you looking for an exciting opportunity to gain hands-on experience in the medical device industry? Look no further than Edwards Lifesciences. We are seeking highly motivated individuals to join our Clinical & Regulatory Internship program. As an intern, you will have the chance to work alongside experienced professionals and contribute to the development and approval of life-saving medical devices. If you have a passion for healthcare and a desire to learn, we want to hear from you. Join us and make a difference in the lives of patients around the world.

  1. Assist with the development and implementation of clinical and regulatory strategies for medical devices.
  2. Conduct research and gather data to support clinical and regulatory submissions.
  3. Assist with the preparation and submission of regulatory documentation, including IDEs, PMAs, and 510(k)s.
  4. Participate in clinical trial activities, including protocol development, data collection and analysis, and monitoring.
  5. Collaborate with cross-functional teams to ensure timely and accurate completion of regulatory submissions.
  6. Keep abreast of industry regulations and guidelines to ensure compliance.
  7. Support the preparation and organization of meetings with regulatory agencies.
  8. Participate in the review and analysis of clinical data to support product development and approval.
  9. Assist with the preparation of reports and presentations for internal and external stakeholders.
  10. Contribute to quality assurance and risk management processes to ensure compliance with regulatory requirements.
  11. Collaborate with team members to identify and implement process improvements.
  12. Participate in training and professional development opportunities to enhance knowledge and skills in clinical and regulatory affairs.
  13. Maintain accurate and organized records of all work performed.
  14. Adhere to company policies and procedures, as well as relevant regulations and standards.
  15. Contribute to a positive and supportive work environment that promotes teamwork and professional growth.
Where is this job?
This job is located at Irvine, CA, USA
Job Qualifications
  • Bachelor's Degree In A Relevant Field Such As Biology, Biomedical Engineering, Or Healthcare Administration.

  • Strong Understanding Of Fda Regulations And Guidelines For Medical Devices.

  • Excellent Organizational And Time Management Skills, With The Ability To Prioritize Tasks And Meet Deadlines.

  • Proficiency In Microsoft Office And Data Analysis Software.

  • Prior Experience In A Clinical Or Regulatory Setting, Such As An Internship Or Coursework, Is Preferred.

Required Skills
  • Quality Assurance

  • Project Management

  • Data Analysis

  • Clinical Research

  • Data Management

  • Scientific writing

  • Regulatory compliance

  • Literature Review

  • FDA regulations

  • Medical Devices

  • Clinical Trials

  • Protocol Development

Soft Skills
  • Communication

  • Conflict Resolution

  • Customer Service

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Clinical & Regulatory Internship in Irvine, CA, USA is $15-$20 per hour. However, this can vary depending on factors such as the specific company, the intern's level of experience and education, and the length of the internship. It is also worth noting that some internships may be unpaid. It is important to research the specific company and internship program to determine the potential salary range.

Additional Information
Edwards Lifesciences is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedSeptember 26th, 2024
Apply BeforeMay 22nd, 2025
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About Edwards Lifesciences

Edwards Lifesciences (NYSE: EW) is the global leader in the science of heart valves and hemodynamic monitoring.

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