Regulatory Compliance Specialist

1 week ago


Gainesville, Florida, United States Exactech Full time

The exactech is seeking a Regulatory Compliance Specialist to join our team. This role will play a critical part in ensuring the company's medical devices comply with regulatory requirements.

About Us

We are Exactech, a leading global medical technology company dedicated to improving patient lives. Our mission is to deliver innovative orthopedic and sports medicine solutions that advance healthcare worldwide.

Job Summary

This Regulatory Compliance Specialist position requires a highly motivated individual with experience in FDA/ISO medical devices quality management system standards. The ideal candidate will have a strong background in technical writing, design controls, and regulatory submissions.

Key Responsibilities
  • Preparing and maintaining FDA pre-market submissions, Canadian device license applications, and international product registrations for medical devices.
  • Assisting in preparing and submitting MDD Class III Design Dossiers for review by the Notified Body.
  • Providing regulatory support for new product development projects, including design team participation, design control requirements, CE marking requirements, and technical file compilation.
  • Ensuring company procedures, processes, and documentation meet required guidelines for maintaining FDA compliance and ISO/EC/CMDR certification.
  • Participating in complaint handling, corrective and preventive action, and internal quality audit processes.
Requirements
  • Bachelor's Degree from an accredited institution required.
  • Minimum 2 years experience in FDA/ISO medical devices quality management system standards required.
  • 2 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations preferred.
Salary Range

$80,000 - $110,000 per year.



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