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Director, Regulatory Lead - Medical Device - Bioelectronics (all genders) @ EMD Group (Merck KGaA / EMD Serono)

Darmstadt, Hesse, DEOnsiteFull-time
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About this role

Join our team as Director, Regulatory Lead – Medical Device – Bioelectronics and drive global regulatory strategy for innovative implantable neurostimulation devices. Lead submissions, engage health authorities, and shape regulatory pathways for cutting-edge medical technology. Make a global impact in healthcare with a diverse, collaborative team at the forefront of bioelectronics innovation.. Category: Regulatory Affairs

Skills

eu medical device regulation (eu-mdr) complianceneurostimulation / bioelectronics device expertisecombination product regulatory strategyglobal regulatory strategy development (medical devices)cross-functional stakeholder management in matrixed organizationsestar process knowledgeide / 510(k) / pma submission managementactive implantable medical device regulation (class iii / aimd)21 cfr part 820 quality system regulationiso 13485 quality management systemsiso 14155 clinical investigation standards

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