Regulatory Affairs Data Analyst
CK QLS are recruiting for a Regulatory Affairs Data Analyst to join a global medical device company at their site based in Zuchwil on a on a contract basis for until the end of the year.
Company: This company is a leading medical device company operating on a global scale.
Location: This Regulatory Affairs Data Analyst will be based at our clients site in Zuchwil.
Responsibilities of the Regulatory Affairs Data Analyst:
- 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.
- 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.
- Strong analytical skills and proficiency in English written and spoken. German in addition, would be an asset.
Apply: For more information or to apply for this Regulatory Affairs Data Analyst, please contact Jocelyn on 0041 (0) 782 516 595 or email email@example.com, quoting job ref 47915.
Please send all of your correspondence in English.
It is essential that applicants hold entitlement to work in the in the country where the services will be delivered.