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Lead Specialist in Regulatory Affairs for Critical Care

2 months ago

Irvine, California, United States Regulatory Affairs Professionals Society Full time
Join Our Team:

At Regulatory Affairs Professionals Society, we are dedicated to advancing the field of regulatory affairs, particularly within the Critical Care sector. Our mission is to ensure that every patient receives the highest standard of care through innovative medical technologies.

Your Role:
As a Senior Regulatory Affairs Specialist, you will play a crucial role in our product development and manufacturing teams. Your responsibilities will include:

  • Providing expert regulatory guidance to ensure compliance with industry standards.
  • Reviewing and approving critical documentation such as protocols, reports, and engineering drawings.
  • Preparing comprehensive submission packages for global regulatory agencies.
  • Monitoring and analyzing global regulatory changes and their implications on ongoing projects.
  • Engaging with regulatory bodies during submission reviews and audits.

What We Expect:
To succeed in this role, you will need:

  • A Bachelor’s Degree in a relevant field with at least 5 years of experience, or a Master’s Degree with 3 years of experience.
  • Strong familiarity with EU and US regulations pertaining to medical devices.
  • Experience in preparing technical documentation for regulatory submissions.
  • Proficiency in Microsoft Office Suite and excellent communication skills.
  • Strong analytical and problem-solving abilities with a keen attention to detail.

Preferred Qualifications:
We value candidates who possess:

  • A degree in a scientific discipline such as Biology or Chemistry.
  • Experience with change management systems and regulatory compliance.
  • Exceptional organizational skills and the ability to manage multiple projects effectively.

We invite you to explore the opportunity to make a significant impact in the field of regulatory affairs.