Medical Devices Group Lead

Medical Devices Group Lead

ProductLife Group

Europe

MAIN RESPONSIBILITIES

  • Implement the Medical Devices Business Development Strategy;
  • Coordinate all activities related to medical devices, regulations, quality and vigilance;
  • Expertise in regulatory files and quality assurance (CE marking files, implementation of ISO 13485, audits, risk analysis, preparation of international registration dossiers);
  • Writing and submission of CE marking dossiers;
  • Team supervision.

Education

  • Master’s in science.

Experience

  • 10 years of experience in regulatory and quality assurance of medical devices;
  • Management experience is a plus.

Skills

  • Consulting mindset;
  • Project and people management;
  • Expert in quality assurance and regulatory affairs (CE/FDA) for medical devices;
  • Skills for the implementation of QMS/revisions, quality issues, risk analysis, CE marking, FDA 510K;
  • Mastery of quality and regulatory standards DM: EU 2017/745 – EU 2017/746 – ISO 13485/14 971 standards;
  • Deep knowledge of MDR.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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