IVDR_Regulatory Affairs / quality specialist consultant_ ISO 15189 and IVD

  • Jornada completa
  • En remoto

CMG MedDev

What are we looking for?

We are looking for a graduate or post doc, who is enthusiastic, involved, with organizational skills and a strong commitment to teamwork.

With demonstrable knowledge and experience no less than 4 years in the following areas:

  • ISO 15189, ISO 14971, ISO 17025 and valuable IEC 62304 and ISO 13485- development and implementation of QMS, RA and MDSW specific documents.
  • IVDR 2017/746, MDCGs.
  • Thorough knowledge of any or all of the following techniques: NGS, Molecular and Immunohistochemical technologies.
  • Expertise in the validation of all or some of the above techniques.
  • Valuable knowledge to develop TDs.
  • Valuable knowledge to develop PEP, PER (included scientific, analytical and clinical evaluation), PMPF.

What we offer

  • Permanent contract, salary according to the employee’s skills and competence and the requirements of the position.
  • Team attendance at congresses and learning forums.
  • Continuous training.
  • Working in an organization of 10 employees, close, with direct relationship with the CEO, a person of recognized prestige and knowledge in the sector; and working in a team.
  • 100% remote working mode. The company provides you with the necessary tools for its development.
  • Pleasant working environment.

Responsibilities

  • Be autonomous in the leadership and execution of projects to obtain CE marking of products.
  • Report weekly to your superior on the progress of the projects.
  • Establish the most suitable regulatory strategy for the customer.
  • Development of the customer’s QMS documents and support in their implementation.
  • Development with the client of the TD of the product.
  • Interactions with ON.
  • Periodic meetings with client for the progress of each project and for the resolution of doubts or explanation of concepts.
  • Development of web publications related to technical aspects of your position.
  • Development of presentations for congresses.

Do you like what we propose? Do you want to be part of this selection process?

Send us your CV to the following emails

carmen.martin@cmgmeddev.com

Luisfe.burrieza@cmgmeddev.com

We will be happy to receive it, evaluate it, and invite you for an interview.

Para solicitar este trabajo envía un correo electrónico con tus detalles a administracion@bioval.org