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Regulatory Affairs Specialist
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Plm, Erp, Product lifecycle management, Client
Projektbeschreibung
Are you an outstanding RA SPECIALIST with experience in the area of medical devices? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!
Our client, an international pharmaceutical company based in ZUCHWIL, is looking for somebody like you to become a new REGULATORY AFFAIRS SPECIALIST.
PROJECT:
We are looking for a 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.
Location: Zuchwil (canton of Solothurn)
Duration: 12 months
DUTIES & RESPONSIBILITIES:
- 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.
We are looking for somebody with:
- 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
- Ability to work on multiple simultaneous tasks with limited supervision
- Excellent customer service, interpersonal, communication and team collaboration skills
- Ability to follow change management for internal guidelines
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career!
Our client, an international pharmaceutical company based in ZUCHWIL, is looking for somebody like you to become a new REGULATORY AFFAIRS SPECIALIST.
PROJECT:
We are looking for a 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.
Location: Zuchwil (canton of Solothurn)
Duration: 12 months
DUTIES & RESPONSIBILITIES:
- 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.
We are looking for somebody with:
- 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
- Ability to work on multiple simultaneous tasks with limited supervision
- Excellent customer service, interpersonal, communication and team collaboration skills
- Ability to follow change management for internal guidelines
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career!
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik