The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Surgenex seeks to add a full time Director of Quality Assurance to our growing team at its Scottsdale, AZ location. Responsible for setting and executing short- and long-term goals and objectives related to quality assurance and quality control. Establish, implement, and maintain systems, policies, and procedures to ensure compliance with all relevant regulations and standards set forth by the FDA, AATB, and other state, local, and international regulatory bodies. Oversee and maintain licensing, registration, and accreditation with relevant regulatory bodies. Host federal, state, and other accrediting bodies in regulatory audits and inspections. Oversees the day-to-day activities related to the quality and safety of tissue products.
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