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.
Biologics, Biotechnology, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
In this role, you will be primarily responsible for handling regulatory affairs requirements for medical devices and biologic and products, including Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). You will develop regulatory strategies and regulatory submissions for new and modified products to the FDA and International regulatory bodies. This individual will also provide regulatory support and guidance for product changes to US marketed products.
Other job requirements include:
Working closely with process development, manufacturing and quality departments to support the preparation of domestic and international regulatory submissions. This includes writing, reviewing, and editing technical reports and regulatory documentation.
Providing input on and review of protocols and reports including but not limited to process validation, equipment qualification, and shelf-life studies.
Ensuring regulatory compliance with QSR and cGMP requirements and stay apprised of ICH, FDA and EU requirements.
Evaluating changes to determine the filing requirements and impact on AATB certifications, state licenses, and FDA registrations.
Review of labeling changes, and advertising and promotional material.
Review of complaints for medical device reporting (MDR) requirements.
Education and Experience:
A BS degree is required and a degree in science, technology, engineering, or mathematics is preferred. Working knowledge of FDA and International Biologics/Drug/Device regulations is preferred. In addition, prior experience with medical devices development and registrations is a plus. Ability to prioritize and multi-task projects independently is preferred. Strong organizational, interpersonal and written/verbal communication skills are required.
Internal Number: 651
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