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About the role
Key responsibilities & impact- Owning clinical compliance and the regulatory roadmap: Taking ownership of medical device classifications and DCB documentation, and driving Class IIa medical device regulation for our products.
- Driving certification through to completion: Owning timely audits, compliance, and submissions, while building out the QMS and the processes within the team.
- Shaping the healthcare product roadmap: Working hand-in-hand with the PM and product team on healthcare-required initiatives, from ongoing clinical evaluations to integrations with NHS EPR systems.
- Being the subject-matter expert: Acting as the go-to authority on clinical status and medical device regulation, training the team, and engaging the MHRA and DHSC to keep a long-term view of likely changes, including international equivalent standards and regulations outside the UK.
- Driving operational excellence: Setting a clear roadmap for healthcare operations and compliance initiatives, agreeing priorities and resourcing, and knowing when to bring in external contractors, agencies, or new hires.
- Keeping everyone aligned: Making sure every team that interfaces with this role – Commercial, Product, Legal, Trust and Safety, Senior Leadership, and our Clinical Safety Officer – has a clear sense of what is happening, when, why, and who owns it.
Requirements
What you’ll need- A Compliance Manager with experience owning clinical compliance and regulation roadmap (Medical Device Classifications; DCB docs), including driving Class IIa medical device regulation.
- An expert in working with PMs on healthcare-required product roadmaps (e.g. ongoing clinical evaluations; integrations with NHS EPR systems; etc.).
- A skilled project manager in complex, multi-functional environments related to compliance - coordinating across teams to deliver at pace.
- A Detail-Oriented Operator: You have a sharp eye for detail and take pride in getting complex regulatory work exactly right, with precision and consistency.
- A Reliable Independent Worker: You are a dependable executor who just gets the job done. You don't need constant hand-holding, but you are also a fantastic, collaborative teammate.
- Technically Curious: You are comfortable talking about products and AI, eager to learn how data flows across our infrastructure, and able to work closely with product and engineering on integrations.
- A Clear Communicator: You effortlessly engage stakeholders, break down regulatory nuance, and are an active, empathetic listener - confident and credible in customer-facing situations.
- Commercially Minded and Driven: You understand that a lot of the compliance roadmap will be shaped by commercial priorities, and you build and drive team momentum.
Benefits
Comp & perks- Top-tier coaching and personal development budgets
- Competitive salaries
ATS Keywords
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Hard Skills & Tools
Medical Device ClassificationsDCB DocumentationClass IIa Medical Device RegulationRegulatory AuditsQuality Management System (QMS)Clinical EvaluationsNHS EPR Systems IntegrationRegulatory SubmissionsOperational ExcellenceCompliance Initiatives
Soft Skills
Detail-OrientedReliable Independent WorkerCollaborative TeammateClear CommunicatorCommercially Minded