This section is for individuals who are new or relatively new to the profession with limited or no regulatory knowledge, and minimal experience in the healthcare product industry or the regulatory field. Many 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 and begin to develop the critical thinking skills essential to the profession.
At this level, you 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, research regulations and guidance and maintain and organize key information sources. (Example job titles: coordinator and some associate positions)
In this section:
Overview by Typical Position Titles for the New Regulatory Profession (Level I)
Knowledge and Skills of the New Regulatory Professional (Level I)
Recommended Reading
Articles and books to help you succeed and advance at this level in your career.
Professional Development
Continue your learning and plan your professional development. A wide variety of education and training opportunities are available.
Additional Resources:
Job Search Resources
Job search resources available from RAPS.
Networking
RAPS offers unprecedented opportunities for networking.