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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical compliance and regulatory management for medical devices, including Class IIa regulations and DCB documentation. Proven ability to collaborate across teams, drive operational excellence, and communicate effectively with stakeholders in a healthcare environment.
Highest-signal resume keywords
Clinical Compliance ManagementMedical Device RegulationProject ManagementStakeholder CommunicationHealthcare Product Roadmap Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
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
Industry Keywords
Healthcare ComplianceRegulatory RoadmapMHRA EngagementDHSC EngagementInternational Standards
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