medical devices specialist a POMEZIA

pubblicato
offerta proposta da
tipo di contratto
somministrazione
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pubblicato
luogo di lavoro
pomezia, lazio
categoria
Ingegneria
sottocategoria
Biomedico
tipo di contratto
somministrazione
riferimento
CX153766
offerta proposta da
gruppojj@randstad.it

descrizione

For a multinational company in the chemical-pharmaceutical field, we are looking for a Medical Devices Specialist who will manage the European regulatory activity (MDR), ensuring compliance, carrying out research with clinical studies and identifying data gaps in medical devices.

responsabilità

Main tasks:

  • Medical input for technical file and other documents for Regulatory and Quality groups in support of MDR Cadence execution;
  • Research, prepare and document responses to Medical Informations Requests (MIR);
  • Review medical content in Copy Approval process, consulting with Franchise Medical Director, when needed, in support of MDR Cadence Execution;
  • Input to cross functional team with respect to evidence assessment, literature review, analysis and conclusion for Clinical Evaluation Report per MDR Cadence Execution;
  • Review and input for risk management documents and product labeling for MDR Cadence Execution;

competenze

Main features required:

  • General knowledge of surgery and surgical conditions;
  • Experience in scientific literature review, analysis and conclusions;
  • Fluency in English both written and spoken, other EMEA languages are a plus;
  • Excellent presentation skills;
  • Extended experience in using IT tools, including Microsoft Office;
  • A current license to practice Medicine and board certification in a surgical specialty are preferred;
  • Previous exposure to MDR activities would be a plus.
  • Risk Management competences would be a plus also.

We offer a 1- year part-time contract with the possibility of both personal and professional growth. Ral 40K.

 

Work area: Pomezia (RM) and from remote.

livello di studio

Laurea specialistica o a ciclo unico
I candidati ambosessi (L.903/77) sono invitati a leggere l’informativa sulla privacy ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).