Find a position that matches your potential.

Our client a cutting-edge medical device company. They are currently seeking a Regulatory & Quality Manager to join their team in the Southeast.

What’s in it for you…

• Well-established, family-owned business – current CEO is 5th generation
• Stable, profitable and continuing to grow
• Very tenured employees – all very loyal to the company
• Incredible opportunity to do everything there is in Quality & Regulatory and what you don’t know now the opportunity is there to learn it
• Significant advancement opportunities – right-hand person to Sr. Director

To be considered for an interview, the following experience/skills are desired:

• Bachelor’s degree in Engineering, Science, or related field
• 10+ years experience in the medical industry experience in quality control, quality assurance and regulatory affairs required (includes submissions experience – mainly for FDA 510(k)s and some EU)
• Competence in applying and assuring compliance to QSR and ISO 13485 requirements per FDA and EU MDR requirements (including interfacing with involved regulatory agencies such as FDA)
• Hands-on, individual contributor and a self-starter who is results-oriented; must be a go-getter, someone who wants to learn

Salary: Maximum $155K base plus bonus

If you experience technical difficulty while applying to the position, please email your resume directly to MedicalDeviceTeam@MRIGlobalMedDevice.com