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Regulatory Specialist - Knee

Florida, FL

Industry: Regulatory Affairs Job Number: 2026

Position Overview

As a regulatory specialist for a major Orthopedics manufacturer you will prepare and maintain FDA & international product registrations for medical devices.

Primary Responsibilities:

  • Ensure that all procedures, processes, and documentation meet guidelines for FDA compliance, including Design Control & Risk Management processes
  • Prepare & Maintain FDA pre-market submissions as well as international product registrations
  • Prepare & Maintain CE Mark Design Dossiers and Technical File for review by the Notified Body
  • Provide regulatory support for new product development process
  • Participate in complaint handling process, internal quality audit process, and CAPA activities.
  • Review and approve product labelling
  • Provide support and guidance for other employees as necessary

Position Requirements:

  • 2+ Years Experience in FDA/ISO Medical Device Quality Management Systems
  • Experience in preparing FDA pre-market submissions (whether 510(k) and/or PMA) and international registrations highly preferred
  • Nuanced understanding in Design Control

Education Requirements:

  • Bachelors 

Location: Southeast

Compensation: Commensurate with Experience

FDA pre-market submissions (510(k)

Arshad Alam

Arshad is a seasoned recruiter in the healthcare space with over 15 years of experience in promoting career growth for healthcare professionals. He has played a critical role in the launch of several startup companies. He is known for versatility and leadership; expert in overseeing high-level priorities and a broad range of responsibilities.

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