Compliance and Regulatory Affairs Expert

2 weeks ago

Irvine, California, United States Brett Fisher Group Full time
Regulatory Affairs Specialist

Why Consider This Opportunity?

Brett Fisher Group is a leading entity in the manufacturing and distribution of medical devices, with a strong focus on anesthesia and respiratory solutions. The company has a global presence, operating in numerous countries and maintaining several manufacturing facilities worldwide.

The Regulatory Affairs Specialist will be instrumental in overseeing regulatory matters, with a primary emphasis on the United States market. Key responsibilities include securing and upholding all necessary federal and state regulatory approvals, ensuring adherence to regulatory standards, and offering strategic guidance.

This role presents a remarkable chance to be part of an organization recognized for its dedication to quality, service, and customer satisfaction. Join a dynamic team that is experiencing significant growth in the US sector.

Core Responsibilities:

  • Formulate regulatory strategies and submissions for FDA and state regulatory bodies.
  • Provide regulatory support to product development teams.
  • Evaluate technical documentation for compliance with regulatory criteria.
  • Assist in the renewal, updating, and registration of licenses.
  • Ensure that marketing materials meet regulatory standards.
  • Stay informed about QSR and ISO requirements.
  • Support Quality Management activities as necessary.

Qualifications & Skills:

  • Bachelor's degree in Science, Engineering, or a related discipline.
  • A minimum of 3 years of experience in regulatory affairs within the medical device sector.
  • Familiarity with global medical device regulations is advantageous.
  • Strong project management capabilities.
  • Effective communication skills with regulatory agencies.
  • Experience with FDA and Notified Body inspections.
  • Professional certifications are beneficial.
  • Knowledge of 510k submissions is preferred.
  • Understanding of both domestic and international regulations.
  • Authorization to work in the US is required.
  • California Designated Representative in Charge license is a plus.

Work Environment: This position is based in an office setting at the company's headquarters. Occasional travel may be necessary for inspections or regulatory discussions.

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