Regulatory Affairs Senior Specialist

LausanneFixe2018-07-05Master / Université
Our Client, an international Medical Device Group, is recruiting a Senior Specialist Regulatory Affairs to complete the team.

Regulatory Affairs Senior Specialist

Responsibilities

  • Medical Device Regulation (MDR) Project Manager
  • Promotes / communicates awareness of regulatory requirements throughout the organization
  • Manage QA/RA key projects within the company
  • Keeps information regarding standards and regulations concerning medical devices and their manufacturers up-to-date together with the Regulatory Affairs Manager
  • Coordinates Post Market activities such as complaints, vigilance reporting and resulting actions for injector families
  • Supports maintenance of Technical Files such EC technical Files, 510(k) for his/her dedicated product line
  • Support maintenance of Risk Management File with Risk Management Coordinator for his/her dedicated product line
  • Coordinates and executes standards surveillance for all Products and act as web tool administrator on the related platform.
  • Participates during notified body audit and other inspections
  • Establishes procedures for maintaining compliance with regulatory standards


Profile

Engineering or University degree preferably in a field that offers as opportunity to gain all-around background.
5+ years of previous experience in a medical device or pharmaceutical environment
  • Knowledge in management of complex QA/RA Projects
  • Good communication and strong interpersonal skills
  • Very good knowledge of MS Office
  • High personal commitment
  • Able to work independently and flexible to change priorities
  • Fluent in English and French language both written and oral, other European language skills are an asset


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La référence de cette offre est JN -072018-50158

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