Checks that all healthcare and medical products are following appropriate legislation and guidelines before sale and distribution.
Overview
The regulatory affairs specialist (degree) was approved for delivery on 08/11/2018. This Higher apprenticeship standard awards you with a level 7, non-integrated degree qualification when completed. The usual duration of this apprenticeship is 30 months, but this does not include the End-Point Assessment Period.
What the course covers
The Regulatory Affairs Specialist inspects organisations to check that their products are appropriately licensed. They must ensure that the relevant authority has provided the license and that the company is complying with the appropriate laws, including notifying the appropriated bodies. As such, the apprentice will work in a variety of environments, with numerous different clients or licensing bodies.
A Regulatory Affairs Specialist is responsible for ensuring businesses follow the UK’s commercial laws, but also to assist enterprises in that process. This includes developing strategies with appropriate stakeholders, researching regulatory issues, managing applications, creating and delivering compliance plans, and ensuring that all clients stay up to date with all processes and standards.
Failure by an apprentice to accurately and appropriately carry out their tasks could have dangerous consequences. Not only would there be major financial and legal consequences for the client, but also the potential for critical health risks to the consumer, be they humans or animals. As such, a rigorous and up-to-date understanding of all regulations and standards is essential. Additionally, the apprentice must be very critical in their analyses, as well as being able to take accountability for any mistakes.
Careers and jobs associated
- Regulatory Associate
- Regulatory Strategist
- Regulatory Executive
- Regulatory Affairs Manager
- Regulatory Compliance Professional
- Medical Device Competent Person.
If you would like to find out more about the regulatory affairs specialist (degree) apprenticeship standard, skills, learnt, assessment methods and duties of the role, visit the Institute for Apprenticeships.
