Regulatory Affairs Specialist (German Speaker)
Regulatory Affairs Specialist (German Speaker)
On behalf of our client, one of the biggest medical devices company based in Zuchwil we are looking for a Regulatory Affairs Specialist with previous experience Product Lifecycle Management (PLM).
This is a contracting position, starting in April until the end of the year with extension possibilities.
Primary Tasks and responsibilities
- 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
Your skills/experiences are:
- 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) 2017/745)
- Understanding of requirements of current Council Directive 93/42/EEC
- 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
- Able to follow change management procedures and internal guideline
- Quick learner, motivated self-starter
- Strong analytical and problem-solving skills
- Fluent in English and Swiss German
Start: 01.04.2020
End: 31.12.2020
Location: Zuchwil
Workload: 100%
If you are a result-oriented RA currently looking for a challenging new position that applies to your skills, then we look forward to receiving your application!
I'm always looking for skilled IT Experts so please don't hesitate to send me your CV.
Not the right job for you? Since new jobs are coming in every day just give me a call +41 (0)61 282 22 17. Experis, the leading IT recruitment agency in Switzerland has many open jobs, just browse our website now to find interesting professional opportunities!
