regulatory affairs data analyst in medical devices in Solothurn

posted
contact
Lucie Nasshan, Basel Professionals Health Care & Life Sciences
job type
temporary
apply now

job details

posted
location
solothurn
sector
Life Sciences
job type
temporary
reference number
11989
contact
lucie nasshan, basel professionals health care & life sciences
phone
058 201 55 50
apply now

job description

Randstad Professionals is currently looking for a Regulatory Affairs Data Analyst in Medical Devices who will be assigned an interesting challenge for a major client based in Solothurn.

This contract is a great opportunity to join a major client, global group focusing on the Healthcare sector (Medical device, Pharma/vaccines, Consumer health).

The initial assignment will start ASAP ( december 2018) and will last until December 2019.

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.

Tasks:

  • 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.

Candidates’s profile :

  • 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

  • Strong analytical skills and proficiency in English written and spoken. German in addition, would be an asset.