Senior Regulatory Affairs Specialist (m/f)

Solothurn  ‐ Onsite
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Description



Senior Regulatory Affairs Specialist (m/f)

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

Main tasks:
  • Project name: MDR RA-Tech Files
  • Support local franchise Regulatory team for various activities in conjunction with MDR compliance work
  • Support preparation of technical documentation or design dossier documentation for submission to and review by Notified Bodies, as required (both MDD and MDR)
  • Provide regulatory support for New Project Development projects as assigned with focus on CE marking (under MDD as well as MDR) and US requirements (510(k))
  • Provide regulatory support for Life Cycle Management project 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
  • 4 Profound experience in Medical Device Industry and Regulatory Affairs.
  • 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 within Regulatory Affairs at DePuy Synthes preferred
  • Experience with creation and maintenance of Technical Documentation in PLM Systems preferred
  • Experience in IT system documentation and database management preferred
  • Experienced skills in MS Office (Excel, Access) for data analyses and comparisons
  • Ability to comprehend principles of engineering, physiology and medical device use.
  • 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:
Birgit Viktoria Huber

Referencenumber:


Make contact:
Email:
Start date
12/18
Duration
12 MM++
(extension possible)
From
Hays AG
Published at
29.11.2018
Contact person:
Kerstin Werner
Project ID:
1676009
Contract type
Freelance
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