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.




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.



* 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


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

Job Types: Full-time, Permanent

Type d’emploi

Temps plein

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