Regulatory Affairs Specialist

4 days ago


Irvine, California, United States Gable Search Group Full time
{"Job Title": "Regulatory Affairs Specialist", "Job Responsibilities": "

As a key member of our team, you will provide guidance on regulatory requirements and assist in regulatory-related projects and tasks to ensure compliance with FDA regulations, ISO standards, and other regulatory agencies.

Key Responsibilities:

  • Develop and implement regulatory strategic plans to ensure compliance with regulatory requirements.
  • Represent regulatory affairs on product development and commercialization teams.
  • Ensure compliance with standards and execution of corrective actions.
  • Prepare and oversee documentation packages for submission to global regulatory agencies.
  • Assist with customer complaints and CAPA system.
  • Develop risk assessment review process for all marketed devices.
  • Monitor proposed and current US and EU regulations and guidance.
  • Review documents for regulatory claims and promotional material.

Requirements:

  • Strong working knowledge of US and EU regulations that affect Class III medical devices.
  • Experience working on cross-functional projects.
  • Fluent English with strong written and verbal communication skills.
  • Excellent analytical thinking and problem-solving skills.

What We Offer:

  • Competitive salaries and performance-based incentives.
  • Employer-paid benefits programs.
", "Company": "Gable Search Group"}

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