Regulatory & Quality Manager

Find a position that matches your potential.

Our client, a cutting-edge medical device company, is 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 learn what you don’t know now
• 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 in quality control, quality assurance, and regulatory affairs (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