Regulatory Lead – In Vitro Diagnostics - Europe

Regulatory Lead – In Vitro Diagnostics - Europe

Eurogentec

Loos, France

Within the Global Diagnostics team, you will be developing and executing against the regulatory strategy for FDA submissions of novel In Vitro Diagnostic (IVD) tests, with the ultimate objective of supporting formal marketing approval in Europe. This position reports solid line to the Head of Global Diagnostics and dotted-line to the Global Regulatory Affairs Head.

MISSIONS:

  • Your responsibilities include, but are not limited to:
  • To participate in the definition and evolution of the regulatory strategy for in vitro diagnostics in Europe;
  • To coordinate in the preparation, drafting and cross-functional review of the technical files/Design History File (DHF) and design control documents for regulatory submission;
  • To define, coordinate and deliver risk analysis and mitigation strategies for regulatory submissions;
  • To monitor the regulatory landscape to properly anticipate changes that may impact the commercial strategies/timelines;
  • To manage relationships with the regulatory consultants and external organizations related to regulatory submissions, internal/external audits and inspections in collaboration with other departments (e.g. quality).

PROFILE:

  • You hold a Master’s degree in a scientific field;
  • You have a minimum of 5 years experience in regulatory affairs in the medical devices, or preferably, in vitro diagnostic medical devices space;
  • You have a comprehensive working knowledge of the CE submission process and familiarity with upcoming IVDR changes;
  • Experience with the FDA regulatory process including leading engagements with the Agency is a plus;
  • Familiarity with Electronic Document Management (EDM) systems and Microsoft Office Suite in your daily work;
  • Excellent English skills and preferably good knowledge of French;
  • Self starter, you are recognized for your planning and project management skills. You know how to properly set priorities, and you’re not afraid to voice your viewpoints;
  • Exceptional communication and interpersonal skills, with an ability to effectively engage various stakeholders.

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© EuroJobsites 2020

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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