Regulatory Affairs Specialist (m/f)

Solothurn  ‐ Vor Ort
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Beschreibung



Regulatory Affairs Specialist (m/f)

Reference: -en
Start: 12/18
Duration: 12 MM++

Main tasks:
  • For this role we are looking for an RA specialist with strong IT skills able to support the local franchise Regulatory team with the creation of an IT System documentation and other activities in conjunction with MDR compliance work
  • Support RA Business Lead in development and creation of IT System documentation for new functionality related to Technical Documentation requirements under MDR
  • Perform User Acceptance Testing of newly implemented IT requirements as assigned
  • Provide regulatory support for Life Cycle Management projects as assigned
  • Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned.
  • Perform Regulatory Change assessments as assigned
  • Perform Labeling and Promotional Material Reviews as assigned


Main qualifications
  • Experience in IT system documentation and database management (Product Lifecycle Management (PLM))
  • Understanding of MDR requirements regarding required content of Technical Documentation
  • (Focus on ANNEX II of Regulation (EU) )
  • Understanding of requirements of current Council Directive 93/42/EEC
  • Previous experience at DePuy Synthes preferred
  • Comprehensive knowledge in the handling with and of data in PLM and ERP system, preferentially experience in Agile e6, ERP (SAP), Windchill
  • Experienced skills in MS Office (Excel, Word, Access) for data analyses and comparisons
  • Strong analytical skills and proficiency in English written and spoken. German in addition, would be an asset.


Main advantages:
  • Fascinating, innovative environment in an international atmosphere
  • Interesting assignments at renowned national and international companies
  • We will give you valuable tips and feedback on your application documents and interviews



About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

My contact at Hays:

My contact person:
Eden Lara Gordon

Referencenumber:


Make contact:
Email:
Start
12/18
Dauer
12 MM++
(Verlängerung möglich)
Von
Hays AG
Eingestellt
29.11.2018
Ansprechpartner:
Kerstin Werner
Projekt-ID:
1676010
Vertragsart
Freiberuflich
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