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Director of Regulatory Affairs & Quality Assurance

Director of Regulatory Affairs & Quality Assurance

Omega Medical Imaging LLCSanford, FL, US
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Omega Medical Imaging is the world leader in FDA-cleared interventional X-ray systems with cutting-edge AI-driven radiation reduction technology.

We’re passionate about innovation that protects patients and clinical teams and want to see this technology become an industry standard.

The Role :

  • We’re seeking a proactive, experienced leader to innovate and manage our Quality Management System (QMS) and regulatory activities.
  • In this on-site role ( no remote ), you will ensure full compliance with FDA, CE, ISO 13485, and related standards while supporting fast-paced innovation and growth.
  • You’ll work closely with R&D, Manufacturing, and Customer Service to deliver safe, high-quality products.

Key Responsibilities :

  • Lead and continuously improve Omega’s QMS to ensure regulatory compliance and product excellence.
  • Guide 510(k) submissions, CE marking, and support FDA / CE audits and inspections.
  • Manage CAPA, complaints, audits, employee training, and document control.
  • Promote a culture of quality and compliance that aligns with our values and mission.
  • Provide clear, data-driven reports on QMS performance to leadership.
  • Be on-site (not remote).

    • Requirements :

  • Bachelor’s degree in a relevant field. 5+ years of hands-on regulatory and quality assurance experience with Class II electromechanical medical devices, preferably with software.
  • Proven track record navigating FDA GMP / QSR, 510(k) submissions, CE Mark, and ISO 13485.
  • Strong leadership, collaboration, and communication skills suited for a nimble, entrepreneurial environment.
  • Exceptional technical writing and problem-solving abilities.
  • Why Omega Medical Imaging?
  • Join a small, innovative team transforming medical imaging technology to enhance safety and care worldwide.
  • Be part of a company where your leadership shapes regulatory strategy and quality culture, driving both compliance and innovation.  We offer competitive salary, PTO package, paid holidays, 401(k) with Safe Harbor Company Match, tuition reimbursement, along with Medical, Dental, Vision, Disability, HSA, and Life Insurance.
  • Omega is proud to be an equal opportunity employer and drug free workplace.
  • All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
  • Must be legally authorized to work in the United States at the time of hire.  We are unable to sponsor visas.   Powered by JazzHR
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