At a Glance
- Tasks: Lead the maintenance and improvement of regulatory systems in a software medical device company.
- Company: Innovative medical device manufacturer prioritising quality and regulatory compliance.
- Benefits: Competitive salary, flexible working hours, and opportunities for professional growth.
- Other info: Join a dynamic team focused on innovation and compliance in healthcare.
- Why this job: Make a real impact on regulatory processes and help shape the future of medical technology.
- Qualifications: Experience in software medical device development and strong organisational skills.
The predicted salary is between 63000 - 77000 £ per year.
The Role We are a software medical device device manufacturer, with 13458 certification and a Class IIa device on the market.
We care deeply about making quality and regulatory compliance a first class citizen, not an afterthought.
We think "doing regulatory" well is a strong competitive advantage, and we have built internal systems, including processes and custom internal tools, to help us do so.
We’re Now Looking For Someone To Take Ownership Of Maintaining And Improving Those Systems, Supporting Us As We Grow Our Team And Commercial Reach.
You’ll Need Prior knowledge/experience of the software medical device development lifecycle Strong ability to design and build good organisational processes and systems A good sense of how software tooling can remove friction and accelerate processes.
Even better if you have built software in the past.
Good communication and cross-function collaboration skills You’d Be Responsible For Understanding the relevant med-dev regulation and keeping up to date with changes, guidances etc.
Designing compliant processes for us (including helping the CTO/Engineering Director to design the software development process, CAPAs, feedback, etc) Training the relevant teams on those SOPs Facilitating risk analysis sessions and maintaining the Risk Management Report Acting as Product Manager for internal regulatory tools—helping us to decide what to build, and, possibly, participating in building them.
Running audits (internal 13485
Regulatory Systems Lead employer: Flok Health
Flok is an exceptional employer, offering a unique opportunity to be at the forefront of AI-native healthcare in a collaborative and beautiful Cambridgeshire countryside setting. With a strong focus on employee growth, comprehensive benefits including medical coverage and equity options, and a culture that champions innovation and teamwork, Flok empowers its employees to make a significant impact in transforming care and outcomes. Join us to work on challenging problems while enjoying a supportive environment that values excellence and personal development.
