What Does a Regulatory Affairs Director Do?
This white paper report describes the professional development framework of the RAPS American Medical Regulatory Affairs Association's Regulatory Affairs (RA) professional. This framework provides a description of the basic knowledge system and related skills of medical regulatory affairs by different product lines, geographical locations and employee types in the four main career stages. This framework is the result of many years of research and development by the RAPS American Society for Medical Regulatory Affairs with the participation and support of its global members. The results of the study demonstrate a deep understanding of the nature of the profession. This framework is based on different professional or career levels, reflects the scope of the health care product life cycle, the responsibilities and tasks of regulatory affairs professionals at each step, and the relevant core knowledge and skills required by professionals. Clearly defined.
Regulatory Affairs Professional Development Framework
- This entry lacks an overview map . Supplementing related content makes the entry more complete and can be upgraded quickly. Come on!
- Chinese name
- RAPS Medical Regulatory Affairs
- Foreign name
- Regulatory Affairs
- This white paper report describes the professional development framework of the RAPS American Medical Regulatory Affairs Association's Regulatory Affairs (RA) professional. This framework provides a description of the basic knowledge system and related skills of medical regulatory affairs by different product lines, geographical locations and employee types in the four main career stages. This framework is the result of many years of research and development by the RAPS American Society for Medical Regulatory Affairs with the participation and support of its global members. The results of the study demonstrate a deep understanding of the nature of the profession. This framework is based on different professional or career levels, reflects the scope of the health care product life cycle, the responsibilities and tasks of regulatory affairs professionals at each step, and the relevant core knowledge and skills required by professionals. Clearly defined.
- Medical regulatory affairs professionals play a vital role in the entire life cycle, from the conception of healthcare products to product obsolescence. They provide strategic, tactical, and operational guidance and support for work within the regulatory framework to develop and provide safe and effective health products to everyone around the world. The continuing scientific evolution and changes in the regulatory environment, healthcare industry, and the general economy determine the dynamic and expanding scope of regulatory affairs professionals. Medical regulatory affairs professionals must continually improve their knowledge and skills to effectively carry out their professional work and make continuous progress.
The American Society for Medical Regulatory Affairs (RAPS) was founded in 1976, and its mission is to lay the foundation for the development and training of a new specialty in health products regulatory affairs. In 1990, an important part of establishing a medical regulatory affairs specialty was implemented, as RAPS introduced a professional certification, the Regulatory Affairs Certification (RAC). RAC was developed based on extensive research into the practice and specific activities of professionals with 3-5 years of regulatory experience. This research has been carried out repeatedly and updated many times, and the scope of research has gradually expanded to professionals related to the European, American and Canadian regulatory systems. [1]
- The Regulatory Affairs Professional Development Framework aims to provide basic guidelines for the scope and development of medical regulatory affairs professionals. This framework provides an overview of professional responsibilities, knowledge and skills in the four stages of professional development. As such, this framework provides individuals, professionals, regulatory affairs managers and mentors, and organizations with a tool for starting a career or career development plan.
This framework is not precisely tailored to the specific structure, product focus, or nature of each organization. Therefore, individuals and organizations should use it as a basis to improve their content with more details about themselves. The Regulatory Affairs Professional Development Framework is also an important tool for developing continuing education programs.
Healthcare Product Life Cycle