Senior Regulatory Affairs Specialist, Critical Care

2 weeks ago

Irvine, California, United States Regulatory Affairs Professionals Society Full time
Join Our Team as a Senior Regulatory Affairs Specialist in Critical Care

For over five decades, the Critical Care division at Regulatory Affairs Professionals Society has been at the forefront of pioneering medical advancements and enhancing patient care.

Our mission is clear: we strive to ensure that every patient requiring monitoring has access to intelligent technology.

If you are a motivated and enthusiastic individual ready to contribute to cutting-edge, industry-leading technology, we encourage you to consider our career opportunities.

We believe that those who join us will embark on an inspiring journey to elevate the quality of care for countless patients globally.


Your Impact:

As a Senior Regulatory Affairs Specialist, you will:

  • Represent the regulatory function on product development and manufacturing teams, providing insights on regulatory requirements and suggesting alternatives to meet these standards while addressing moderately complex conflicts.
  • Review and approve protocols, reports, engineering drawings, procedures, and other essential documentation to ensure compliance with regulatory standards.
  • Offer guidance on regulatory necessities for strategic planning, including the development of preliminary regulatory strategies.
  • Prepare and manage documentation packages for submission to global regulatory bodies, assisting with necessary submissions and tracking timelines.
  • Engage with regulatory agencies during submission reviews and support on-site audits.
  • Monitor evolving global regulations and assess their impact on assigned projects, proposing strategies to leverage regulatory updates for expedited approvals.
  • Review labeling content and product documentation to ensure compliance and accuracy.

Other incidental duties may be assigned as necessary.


Qualifications (Required):


A Bachelor's Degree in a relevant field with 5 years of related experience, or a Master's Degree with 3 years of related experience is required.

Formal training through coursework, seminars, or government and trade associations is preferred.


Preferred Qualifications:
  • A Bachelor's or Master's degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry).
  • Experience in preparing EU design dossiers or technical files and US 510(k) submissions.
  • Comprehensive knowledge of EU and US regulations pertinent to medical devices, particularly Class II and Class III devices.
  • Thorough understanding of requirements for product changes in marketed disposable products (e.g., catheters, minimally invasive sensors).
  • Expertise in change management systems.
  • Proficiency in Microsoft Office Suite, including Word, PowerPoint, and Excel.
  • Exceptional written and verbal communication skills, including negotiation and relationship management.
  • Strong problem-solving, organizational, analytical, and critical thinking abilities.
  • Meticulous attention to detail.

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