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.
Invivoscribe has long established itself as a company built on integrity, innovation, and collaboration. As a team, we develop products and services that improve blood cancer diagnostics. For 25 years, we have stood at forefront of precision diagnostics, and we’re just getting started! We are looking to add a Senior Regulatory Affairs Specialist will help develop the strategic direction and execute the tactical operational aspects of regulatory compliance and submissions for drug-device combination products. S/he will assure regulatory submission projects are completed on time and that related development files are maintained. Core Responsibilities Include: Responsible for generating submissions
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