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Expert regulatory medical devices & drug device combination product

Administration / Secretarial
Aubonne
English

For our client, an international pharmaceutical company based in Aubonne, we are looking for an :Expert regulatory medical devices & drug device combination productTasks and responsibilities :

  • Provide regulatory expertise for development of Drug/Device combination product.
  • Act as the regulatory device lead in developing the Global regulatory strategy for development of new devices that are used in combination or co-packaged with a medicinal product.
  • Work closely with the Device development team and devices QA team to define regulatory requirements and submission timelines.
  • Review of the device Design history files.
  • Assist in the creation and submission of regulatory documents for Health Authorities.
  • Assist in the Lifecycle management of drug/device combination products ?globally.

Requirements:

Requirements:

  • Experience with regulatory requirements for US/EU/ROW countries for medical devices and co-packaged drug/device combination products
  • Understanding of EU-MDR requirements
  • Understanding of International regulatory requirements for Medical Devices and Drug/Device combination products
  • Experience working on Pharma development teams is a plus
  • Experience with notified bodies is a plus
  • Ability to handle software needed to support regulatory function for regulatory submission
  • od MS office kledge (Excel, Office Timeline)
  • Excellent organizational skills, Excellent communication and presentation skills
  • od teamwork skills
  • od interpersonal skills
  • Fluent in English
  • Temporary assignment : 6 -9 months, starting ASAP