Offre emploi : REGULATORY AFFAIRS SPECIALIST (H/F) - CDI - Temps plein


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REGULATORY AFFAIRS SPECIALIST (H/F)

Recruteur

Poste proposé

Type de contrat : CDI

Type d'emploi : Temps plein

Rémunération :

Profil recherché

A propos de notre client :
Our client is a leading global player within the orthopaedic biomedical technology field. Due to extraordinary growth there will be the need to reinforce the existent organization.

Description de l'annonce :
You will be responsible for regulatory support to market orthopaedic products. General function:
- Coordinates and manages international (EU, FDA) regulatory submission process; may author and publish electronic submissions.
- Coordinates and manages the development of dossiers for global registration of products; may author and publish electronic submissions.
- Provides regulatory direction; develops regulatory strategy for new products.
- Oversees development and review, proposed labelling for compliance with applicable EU, US and international regulations.
- Supports, supervises, and participates in the development of the information for use and package inserts, evaluation of promotional and advertising material for compliance with applicable regulations, and reviews of proposed product changes.
- Ensure compliance with company RA policies.
- Communicates with Regulatory, Government and Certification bodies.

Profil recherché :
- At least 2 years of RA experience, preferably in the medical technology area.
Included regulatory submission, dossiers registration, interacting with R. agencies and reviewing labelling.
- Scientific or Engineer degree.
- Demonstrated strong writing and communication skills, ability to communicate effectively at multiple levels, including with Regulatory agencies, superiors and peers.
- Fluency in English, any further european language desiderable.
- Strong attention to details and ability to multitask.
- Functional knowledge of relevant regulatory legislation and ability to stay abreast of both vertical and horizontal regulations to medical devices, biologics, drugs and combination products.
- Strong medical products knowledge.
- Ability to negotiate and to work indipendently.

Michael Page Contact :
Your application will be sent to Stefano Chiei Gamacchio (Zurich office), lpease quote the job reference KSCH29527. ( stefanochieigamacchio@michaelpage.ch )

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