MDR Regulatory Affairs -Tech Files Consultant - Senior , Zuchwil Sentinel IT LLPHELP
|Beschreibung:||MDR Regulatory Affairs -Tech Files Consultant - Senior|
|Firma:||Sentinel IT LLP - Firma bewerten|
|Salär:||zu verhandeln CHF - 40 Std/Woche|
MDR Regulatory Affairs -Tech Files Consultant - Senior
Leading global Medical Device client require a Regulatory Affairs Specialist for a long-term contract in Zuchwil.
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.
* At least 4 years of 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) 2017/745)
* Understanding of requirements of current Council Directive 93/42/EEC
* 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.
Please apply now for more details!