Regulatory affairs specialist (level 7)
Ensuring healthcare products for human and animal use are licensed before being sold or supplied.
- Qualification level
Equivalent to master’s degree.
- Typical duration
- 30 months
- Apprenticeship category
- Health and science
- Maximum funding
Maximum amount government will fund
for apprenticeship training.
- Also known as
- Medical Device Competent Person
- Regulatory Affairs Manager
- Regulatory Associate
- Regulatory Compliance Professional
Skills an apprentice will learn
- Simultaneously coordinate and plan multiple activities/projects in a highly regulated environment, ensuring completion to time, within budget and to an acceptable quality. Deal with complex issues both systematically and creatively.
- Seek and use evidence-based strategies to take decisions in the absence of complete data and in complex and unpredictable situations impartially, fairly and on merit, without bias in an open and transparent manner. Recognise when it is appropriate to refer the decision. Think critically, take accountability and lead decision making processes, outlining any omissions and justifications of the decisions taken.
- Recognise negotiation strategies and use them with direct and diplomatic approaches, obtaining and maintaining the trust and respect of other stakeholders whilst managing complex interdependencies.
- Engage in research and the evaluation of data to assess its suitability to support risk and safety arguments in a structured and logical manner; alert stakeholders to gaps in evidence. Create and offer alternative approaches to mitigate and manage risk where required. Manage the development and application of evidence-based strategies for operational plans. Demonstrate self-direction and originality in problem solving, practise with a high level of autonomy.
- Develop and deliver high level materials that present and communicate complex research information and data analyses to a wide variety of audiences in different settings and through multiple media. Written and oral communication that is effective when influencing, negotiating, facilitating and resolving conflicts in risk and safety management with stakeholders. Develop and deliver management level presentations which resonate with senior stakeholders, both business and technical.
- Research and organise data from various sources, storing the results in a way that optimises retrieval. Develop and manage a network of contacts to share appropriate information and advice. Know when to share information and who to share it with. Use knowledge to improve the efficiency of work where possible.
- Work autonomously on specific areas of responsibility, in particular leading the development and implementation of the regulatory strategy, whilst interacting with colleagues to contribute to the delivery of project outcomes, recognising the contribution of other functional team members.
- Select and use appropriate and required IT systems in support of the regulatory function.
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