Sr. Regulatory Affairs Specialist

Location
92618, Irvine
Salary
$90-100k
Posted
Jul 12, 2018
Required Education
Bachelors Degree
Position Type
Full time

Medical Device company is seeking a Regulatory Affairs Specialist to join their team!

Responsibilities

  • Prepare FDA submissions (i.e. 510(k), Pre-Sub, IDE, PMA) including writing the text, analyzing relevant documents (e.g. test reports, protocols, labeling, design requirements, manuals), and preparing documentation that will accompany the submission
  • Support international and domestic filings/registrations, including updating technical files and design dossiers;
  • Provide proactive knowledge and expertise as a representative of Regulatory Affairs on project teams;
  • Demonstrate technical and product-related industry knowledge and understanding of a product’s distinguishing features in the market;
  • Analyze advertising, labeling and public communications for regulatory compliance;
  • Ensure compliance with design control regulations during product development and delivery activities;
  • Report any significant regulatory issues related to a product’s release;
  • May represent RA department in project meetings and provide regulatory guidance;
  • Support Quality teams with special projects.

Minimum Qualifications

  • BS in Sciences or Engineering
  • 510(k) Submission, Design Dossiers, and Technical Files.
  • 5+ years of experience