Professions are characterized by several factors, including an identifiable body of knowledge, a pathway for advancing knowledge and skills related to the profession and an emphasis on continued learning and development. The Regulatory Affairs Professionals Society (RAPS) developed the Professional Development Framework (PD Framework) for the healthcare product regulatory profession. The PD Framework offers a model for describing the basic body of knowledge and relevant skills for the regulatory profession across product lines, geographic locations and employer types at four major career stages. The PD Framework is based on two primary dimensions:
Level - referring to one of four professional/career levels
Domains - reflect scope of responsibilities throughout the product lifecycle
The levels and domains are organized within the framework by premarket and postmarket stages of product development, strategic planning and interfacing activities. For each level and domain, the PD Framework presents:
- Basic Professional Knowledge
- Institutional Knowledge
- Skills/Abilities
- Tasks/Responsibilities
Level I Framework
If you are new to the regulatory profession, you are a Level I professional. Many Level I professionals have education and/or experience in science, clinical studies or engineering and understand specific aspects of the healthcare product arena. Throughout Level I, these individuals develop basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. Level I professionals should possess skills such as project management, writing, coordination, and interpersonal and communication skills. A science background and basic statistical knowledge are advantages. At this level, individuals coordinate and support technical and scientific regulatory activities. There is less focus on technical skills and more focus on project coordination and support. (Example job titles: coordinator and some associate positions)
The PD Framework is an important tool in planning your professional development.