Dan Clarke

Uk Affiliate Medical Device Sme @Roche

St Albans, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2024 — Present

Uk Affiliate Medical Device Sme @Roche

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Welwyn, GB

EDUCATION

2003 — 2006

Loughborough University

BSc, Chemistry

2016 — 2017

RAPS

Regulatory Affairs Certificate: Medical Devices, Regulatory Affairs

SKILLS

Cross-Functional Team LeadershipBiomaterialsRegulatory AffairsOrthopedicDesign Control510(K) SubmissionsProduct DesignProduct DevelopmentTechnology TransferBiologicsSix SigmaProduct LaunchState of the Art AnalysisLean ManufacturingR&DTechnology EvaluationJoint ReplacementValidationClass Iii Medical DevicesQuality ControlFdaResearchMedical DevicesCapaDhf RemediationFda Custom Device ExemptionHealthcareCe Mark RenewalsBiomedical EngineeringFmeaProcess ImprovementCustom DevicesRisk ManagementSolidworksProject ManagementDesign ControlsAnalytical Method ValidationInhalation Drug DeliveryQuality SystemRegulatory Compliance

ABOUT DAN CLARKE

Over 19 years in the Medical Devices industry with experience in virtually every area of Device Development. Currently I am working for SFL Services as a consulting Senior Manager RA & QA. Prior to that I have worked as an Orthopaedic Product Specialist with the Notified Body, TÜV SÜD and for 12 years before that, I worked on the Manufacturer side in Research, Development, Design Assurance and Regulatory. I have experience in Asthma inhalers,(MDI’s and DPI’s) with 3M Healthcare, Orthobiologics,(Synthetic Bone Graft, Allograft, Demineralized Bone, PRPs, MSCs, etc) with ApaTech/Baxter, and Extreme Orthopaedics (Limb Salvage/Joint Replacement and Custom Devices) with Stanmore/Stryker. During my time with TUV I reviewed Technical Documentation across many types of device areas. I am also a fully qualified BTF Level 2:1 Triathlon Coach and can coach both Club and 1:1 athletes.

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Dan Clarke — Uk Affiliate Medical Device Sme at Roche in St Albans, GB | Unifers