Regulatory and Quality Leadership Professional

2 weeks ago


Ypsilanti, Michigan, United States Entegee Full time
Job Overview

We are seeking a seasoned professional to lead our regulatory and quality efforts for implantable medical devices. This role will be responsible for managing submissions and implementing a Quality Management System (QMS) that meets FDA and EU-MDR requirements.

Key Responsibilities:

  • Develop and implement a QMS for implantable medical devices.
  • Define and manage regulatory requirements for FDA and EU-MDR submissions.
  • Prepare and present quality and regulatory documentation to regulatory bodies.
  • Oversee regulatory audits and ensure compliance with submission deadlines.

Requirements:

  • Proven experience in leading the setup and implementation of a QMS for medical devices.
  • Leadership experience in defining regulatory requirements for medical devices.
  • Extensive experience leading regulatory submissions to FDA and EU-MDR.
  • Direct experience with Class III implantable devices, specifically leading the submission process.

Preferred Skills:

  • Experience with audits, particularly FDA and EU-MDR related.
  • Familiarity with preparing for regulatory audits, including upcoming audits and submission deadlines.

Benefits:

  • Competitive hourly rate: $40.00 to $60.00 per hour.
  • Comprehensive benefit package, including medical, dental, vision, life insurance, short-term disability, and a 401K plan.
  • Opportunities for professional growth and development.


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