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Regulatory affairs specialist (m/w/x)

Feldkirch
A.M.I. GmbH
€ 50.000 pro Jahr
Inserat online seit: 20 Mai
Beschreibung

With innovative products for coloproctology, urology and urogynecology, we improve medical care worldwide. To strengthen our team at the A.M.I. headquarters in Feldkirch, we are looking for a motivated personality in the field of Regulatory Affairs / International Product Approval.


Responsibilities

* Preparation and submission of marketing authorisation dossiers to European authorities
* Coordination and management of international approval processes
* Contact person for regulatory authorities and international distributors
* Analysis of country-specific regulatory requirements and derivation of appropriate measures
* Ensuring regulatory compliance of products, labels, and documentation


Qualifications

* University degree in medical technology, natural sciences or similar
* Care and accuracy in texts and documents
* Ability to prioritize tasks independently
* Very good written and spoken English skills
* Ideally, professional experience in the areas of regulatory affairs, international approval procedures, quality management or a comparable field.


Benefits

* Company canteen
* In-house childcare
* Varied area of responsibility with great creative freedom
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