Regulatory and Governance Affairs Lead
Steering an exciting Health-tech start up to success
Job Role Summary
We’re an exciting start-up looking to rapidly grow our company and accelerate growth globally. We’ve already had amazing traction within the NHS and are rapidly spreading internationally. We are currently performing high quality medical research funded by the National Institute of Health Research with future research projects in the planning phase.
We are looking for a Regulatory and Governance affairs lead to steer us through the evolving landscape to ensure compliance with necessary standards here in the UK and as we expand globally. You will be responsible for Little Journey’s regulation and governance using your insight and experience to develop a strategic regulatory roadmap, new governance frameworks and work with the Little Journey team to embed good practice.
Please get in touch if you are looking for a role that enables you to make a large, positive impact globally.
Regulatory and Governance Affairs Lead at Little Journey
This role requires a deep understanding of the evolving Governance and Regulatory landscape for digital health technologies, the life science sector and challenges facing health tech SME’s and their quest for globalisation. In addition, knowledge and experience working with healthcare organisations, Contract research organisations and Pharma to understand their needs.
As the Little Journey Regulatory and Governance affairs lead you will:
- Develop and implement a quality and regulatory strategy for the UK, EU and North America.
- Create a detailed roadmap to maintain and continuously improve the governance of our digital solutions.
- Build and implement a framework for our digital platform’s development pipeline, focusing on adoption in new markets and enhancements to the product within existing markets.
- Keep abreast of regulatory developments within or outside of the company as well as evolving best practices in governance.
- Ensure that effective systems and controls are in place to meet regulatory, legislative and corporate governance requirements.
- Work collaboratively with the Little Journey team to address any governance or regulatory deficiencies or risks.
- Lead the development, management and review of SOPs and other Quality Management Documents.
- Support the Little Journey team in embedding good regulatory and governance processes into practice.
- Work with external consultants (such as DPO) as required to monitor any new standards, risks or changes in legislation that may impact the company.
- Working with the commercial team, manage new and existing client relationships – specifically understanding their governance and regulatory requirements, ensuring their needs are met.
- Act as a general liaison with regulatory agencies
As the Little Journey Regulatory & Governance lead, you will be expected to work full time to achieve the above objectives. You will be working closely with the Little Journey executive team, reporting to the CEO, CTO and board. The role can be performed in a hybrid fashion with the 3-4 days per week performed remotely as required. As well as available working space, we will hold regular face-to-face team meetings to support a cohesive and inclusive working environment.
We believe you will:
- Have an intimate understanding of the regulatory and governance challenges faced by health tech SMEs.
- Have sound knowledge of the relevant regulations, standards and requirements (e.g. MDR, ISO 27001/9001/13485, HIPAA, GDPR, Cyber essentials plus, DSP toolkit).
- Have practical experience managing and maintaining ISO compliant products with strong operational governance processes.
- Have knowledge and experience with global (country/local) regulatory and legal requirements related.
- Be passionate about our mission to support children to better health.
- Be able to identify new requirements, lead and embed good practice across he Little Journey team.
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