Regulatory Affairs Manager at Phaidon EPM London | Torre
Regulatory Affairs Manager
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Regulatory Affairs Manager

Phaidon EPM London
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You'll lead regulatory strategy for novel oncology diagnostics, enabling personalized treatment pathways.
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Full-time

Legal agreement: Employment

USD75.4K - 100K/year

~COP150M - 200M/year

+ Equity

+ Bonuses

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Berlin, Germany
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Shared by
Julien PETIT
 8 days ago

Requirements and responsibilities

Role OverviewWe are seeking a Regulatory Affairs Manager to lead regulatory activities across Europe and support international expansion. You will play a key role in ensuring compliance and driving approvals for novel diagnostic technologies.Key ResponsibilitiesLead regulatory strategy and submissions (EU MDR and international markets)Manage and maintain CE marking and technical documentationAct as the primary contact for notified bodies and regulatory authoritiesEnsure compliance with relevant standards (e.g., ISO 13485, MDR, IVDR where applicable)Provide regulatory guidance to R&D and cross-functional teamsPrepare and review documentation including clinical evaluations, risk management, and labelingMonitor regulatory developments and ensure ongoing complianceSupport audits and inspectionsRequirementsDegree in Life Sciences, Engineering, or a related field5+ years' experience in Regulatory Affairs within medical devicesStrong knowledge of EU MDR (IVD experience is advantageous)Experience with CE marking and technical file preparationUnderstanding of clinical and post-market regulatory requirementsFluency in English (German is a plus)What's On OfferOpportunity to join a fast-growing, innovation-driven MedTech companyExposure to cutting-edge oncology diagnostics technologyCollaborative and dynamic work environmentCompetitive salary and career progression opportunitiesCompanyEPM Scientific is working with an innovative medical device company in the oncology diagnostics space. The organisation develops cutting-edge technologies to support the detection and analysis of cancer cells, enabling more personalised treatment pathways.
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