Regulatory Affairs & Quality Specialist

St Gallen, Switzerland
Regulatory
3690
Full Time
Extremely Competitive Salary, great bonus and benefits.
08-08-2019 02:47 PM

Regulatory Affairs & Quality Specialist

Location; Canton St Gallen, Switzerland


The Company

  • Fantastic Leader in Medical Technology who manufacture high-precision Vascular devices.
  • Incredible opportunity to step into a medium sized organisation and form a crucial part of their team based in North East of Switzerland in the Canton of St Gallen.
  • Beautifully located offices neighboured by the serene Lake Constance to the North and the striking Rhine Valley to the East.


The Role

Implementation & Cooperation in Regulatory Affairs Tasks Implementation & Cooperation in MDR Implementation Leadership & pursuit of CAPA projects Editing Complaints and Vigilance worldwide


Core Tasks

Regulatory Affairs Responsibilities:

  • Worldwide registrations & cooperation with authorities and Notified Bodies worldwide;
  • As Regulatory Affairs & Quality Specialist you will be responsible for documentation such as Instructions for Use, Manuals, Labelling;
  • You will play a crucial part in the participation and the implementation and maintenance of MDR requirements (technical documentation class I; lla; Ill)

Quality Responsibilities:

  • From a Quality perspective you will be responsible for the complaint handling, vigilance reporting;
  • As Regulatory Affairs & Quality specialist you will also be responsible for the opening and implementation of the CAPA processes as well as participation in NCMR bug reports and change processes


Required Experience    
                 

  • Minimum of 3 years’ experience in Quality and/or Regulatory Affairs in the Medical Device Industry
  • Experience with Class II Devices as a minimum (ideally Class III implantable devices)
  • Experience in the CAPA process
  • Ideally experience in Vascular therapy area
  • Ability to speak German and English Fluently


Education  
          

  • Successfully completed studies of Medical / Biology / / science or Engineering degree


Language
 Skills - German and English fluently

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