Regulatory Affairs Senior Specialist - Switzerland

POSITION DUTIES & RESPONSIBILITES:

Compile the technical documentation for CE marking
* Compile documentation for the preparation of 510k and submission in time
* Compile the product registration files for notification / registration of the products in all other countries world wide
* Approve from regulatory standpoint design and QMS changes by assessing the impact on the product registration worldwide.
* Prepare, implement and maintain all needed procedures to support regulatory activities.
* Participate in the post market surveillance activities: Field Safety Corrective action, vigilance, MDR.
* Approve all marketing, sales, advertisement etc. materials
* Maintain monthly KPIs for regulatory activities
* Train the organization in regulatory matters
* Participate in all cross functional teams and influence the decisions from regulatory standpoint.

Qualifications
* Bachelors/MSc degree in engineering, life sciences (e.g., biology, chemistry), information systems, or related field.
* A minimum of 5 of relevant professional experience is required, in regulatory affairs in medical devices (quality experience is a plus).
* Strong knowledge and experience with MDD93/42, MEDDEVs and proven track of experience in interacting with Competent Authorities.
* Experience working with FDA, China and Latin America is a plus.

Contact :

Envoyez moi votre CV en document Word à Monia TAZAMOUCHT à l'adresse m.tazamoucht@nonstop-devices.com ou contactez moi sur le numéro suivant : +33 (0)1 76 75 33 40, Extension 3490.
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