Sr. Specialist, Regulatory Affairs - Critical Care

Edwards Lifesciences   •  

Irvine, CA

Industry: Business Services

  •  

5 - 7 years

Posted 379 days ago

Outstanding opportunity to be a part of a forward thinking regulatory affairs organization. The Senior Specialist, regulatory Affairs will focus on supporting sustaining engineering for our critical care monitoring products. This opportunity presents a unique challenge in refreshing our submissions. We are looking for a diligent Sr. RA professional who works well across functional teams, takes initiative, and enjoys working in a fast paced team environment.   Job Description:

  • Represent regulatory affairs on sustaining engineering, product development and commercialization teams related to Critical Care Monitoring Products.
  • Interacts with FDA and other regulatory bodies for submissions and projects.
  • Will monitor proposed and current US and EU regulations and guidance, and will advise the impact of such regulations and guidance on the company within the scope of assigned
  • Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.
  • Able to collaborate and take direction from team leaders, while working with RA management on resolution of RA issues and strategy.

 Qualifications/Required Skills/Experience and Education:

  • A minimum of five years of experience within medical device regulatory affairs is required, for the Sr. RA role.
  • A Bachelor’s degree is required. A science degree is strongly preferred.
  • Experience with Class II devices preferred. Relevant experience includes, experience with hemodynamic monitoring devices.
  • Experience in preparing US and EU product submissions are required.
  • Must be competent in applying the appropriate l regulatory requirements for new products or product changes as it relates to labeling and advertising of class II and III devices. –
  • Requires familiarity with new product development systems.
  • Must possess a strong working knowledge of US /EU regulations that affect Class II and/or Class III devices.
  • Must have strong written and verbal communication skills, and have experience working on cross functional project
  • Strong ability to problem solve and apply analytical thinking is required.

011942