Medical Device Regulation Specialist

Medical Device Regulation Specialist

COCIR - European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry

Brussels, Belgium

This position is in support of the COCIR work related to the implementation of the Medical Device Regulation (MDR) within the European Affairs Focus Group, which is part of COCIR’s Technical and Regulatory Affairs Committee.

Main responsibilities and tasks:

  • Support COCIR activities on the implementation of the MDR, including activities linked to the European Affairs Focus Group, with specific focus on topics such as Post-Market Surveillance and UDI/Eudamed;
  • Work closely with the Focus Group/Task Force Chairs, the COCIR Technical and Regulatory Affairs Committee, and the COCIR Secretary-General, organize meetings, set-up agendas with the Chairs, prepare meeting documents, write meeting minutes, post documents on the COCIR members-only website on a regular basis, maintain the calendar and the sections up-to-date;
  • Actively monitor new information related to the MDR from European institutions regarding consultations, new draft regulations and directives, and inform the appropriate COCIR members in time; eventually coordinate the review of COCIR comments to those contributions;
  • Actively monitor activities on UDI in DITTA (international trade association);
  • Represent COCIR in relevant established external fora as requested;
  • Assist in preparation of communication documents such as newsletters, press releases etc.;
  • provide dedicated service on MDR to members.

Competencies (skills, knowledge, behaviors):

  • Education: Bachelor in European Studies, Law, Informatics, or Science;
  • Experience: minimum 3 years in EU Affairs with affiliation in medical technology. Familiar with the regulatory environment of medical devices;
  • Languages: English (native speaker would be a plus). French, German, Dutch are optional;
  • IT-knowledge: as a minimum comfortable with MS Office, web-based meetings Soft skills: good interpersonal skills, including multitasking, creative/out-of-box thinking, excellent communication (writing and verbal). A team worker, capable of organizing meetings and briefings for members and officials, outspoken,experienced in project management;
  • Specific skills/other: membership in RAPS or TOPRA would be a plus.

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© EuroJobsites 2019

EuroJobsites is a UK 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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