Senior Regulatory Affairs Project Manager

Tustin, CA

Perm Salary

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Overview

Our client needs a Senior Regulatory Affairs Project Manager who sees the world differently. We’re looking for professionals with 7+ years’ experience in the medical device industry, who don’t see obstacles but opportunity when it comes to assisting people to lead better lives. The Senior Regulatory Affairs Project Manager position is full-time, and is located in Irvine, CA. We’re looking for problem solvers, innovators and those inspired by the work we do in making a difference today and with future generations.

Responsibilities

  • Serves as a member on project teams.
  • Identifies regulatory requirements in each country.
  • Develops worldwide regulatory strategies.
  • Communicates with regulatory agencies on administrative and routine matters.
  • Documents, consolidates and maintains oral and written communication with the regulatory agencies.
  • Develops and maintains regulatory files and records.
  • Reviews change order documents and ascertains impact on current regulatory approvals.
  • Reviews promotional material and labeling for regulatory compliance.

Experience

  • A minimum of seven (7) years of experience in medical device industry.
  • A minimum of seven (7) years of Regulatory Affairs experience.
  • Excellent leadership skills.
  • Proven analytical abilities and organization skills(attention to detail).
  • Ability to work well in a team environment.
  • Ability to comprehend technical documents and concepts.
  • Proficient computer skills (i.e. MS Office).

Education

  • BS/BA degree in Science, Engineering or Medical Technology.

 

847-267-1176