Nov 17, 2021

Regulatory Affairs Specialist

  • Techfirm
Full time Science

Job Description

Descriptif du poste

Description du poste

Let me introduce you shortly Tech'Firm :

Tech'Firm is a Swiss engineering company with more than 20 years of experience and 300 dedicated engineers.

Our motto: Delivering with happiness!

We offer a friendly environment with trustworthy relationships. Our mission is to give meaning to the activities of everyone in the company.

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WE ARE LOOKING FOR OUR NEXT PROJECT MANAGER - REGULATORY AFFAIRS TO GROW OUR TEAM !

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Job summary

Support MDR compliance execution work by acting as project manager who has oversight on ongoing MDR compliance work for Medical Devices and drive completion of MDR deliverables.

* Coordinate and drive resolving of NB questions to submitted Technical Documentation

* Provide regular status updates on MDR compliance progress for Medical Devices to MDR PMO and governance team.

* Facilitate resolving of roadblocks and timeline constraints

* Support execution of project plan for MDR compliance

* Lead regular status update meetings with corresponding teams who are working on individual MDR files and/ or specific topics

* Lead and track cross-functional activities as assigned, such as MDR Indication definition and Technical Documentation submissions to Notified Body

* Provide project management support for activities needed in preparation for MDR compliance as instructed and assigned.

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Requirements

* Experience in the MEDICAL DEVICES industry

* Knowledge of MDR Regulations

* understanding of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745)

* Excellent person interaction skills and reliable and goal oriented work attitude

* Experienced skills in MS Office, especially in MS Project

* Strong analytical skills

* Fluent in ENGLISH SPOKEN AND WRITTEN. German is a plus

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If all of this sounds like you then click on the apply button :-)

Feel free to contact also our HR Alexandre KLINUSKI directly on Linkedin to have more information or by E-mail at a.klinuski@techfirm.ch

Job Types: Full-time, Permanent

Type d’emploi

Temps plein


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