Regulatory Affairs Director - Barcelona, España - Consult Search

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Consult Search
Empresa verificada
Barcelona, España

hace 3 semanas

Isabel García

Publicado por:

Isabel García

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Descripción

Scope:

A fantastic opportunity has presented itself to join a globally renowned 'pure play' Aesthetic Company.

Due to the rapid growth of this business, our client are seeking a high calibre Regulatory Affairs Director to join their team in Barcelona.

This establishment has a portfolio of differentiated, complementary aesthetic technologies with a focus on collagen stimulation.

Their products are experiencing significant growth as they target clinical demand for effective, high quality, longer duration, natural-looking & mínimally invasive treatments.


Responsibilities:


  • Responsible for planning, directing, coordinating, and controlling the regulatory affairs activities.
  • Work closely to the Global Head of Regulatory when analysing and defining regulatory pathways for strategic projects.
  • Develop global regulatory strategies for new and modified medical devices.
  • Provide leadership to crossfunctional teams during new product development.
  • Manage technical guidance and training to crossfunctional teams and other RA members including training on procedures, FDA, MDR guidance documents, and international regulation.
  • Manage activities aimed at obtaining/maintaining the medical CE marking and marketing licenses for energy devices in the different markets worldwide, as well as managing the registration and internationalization processes.
  • Manage the Regulatory Affairs team in the different locations.
  • Responsible for global submissions and requirements related to medical devices.
  • Be integral member of the Post Market Surveillance Team. Ensure compliance with product postmarketing approval requirements.
  • Coordinate submissions for new devices and device change notifications as required.
  • Review protocols and reports to support regulatory compliance and submissions.
  • Approve device labelling for compliance with US, EU and International submissions and applicable regulations.

About You:


  • University degree preferably in Life Sciences, Engineering, or other technical discipline.
  • Minimum 6+ years of experience in a managerial role as Regulatory Affairs Manager/Director in the Medical Devices industry.
  • Vast knowledge of: U.S. Food and Drug Administration (FDA) regulatory pathways and MDR EU regulation.
  • Mandatory strong knowledge of: ISO 13485, IEC 60601, ISO 14971, IEC 62304, ISO 1099
  • Excellent computer skills (including but not limited to Windows and MS Office).
  • Orientation towards achievement and ability to learn
Managed by Oliver Allen
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