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 #J-18808-Ljbffr
Regulatory Affairs Specialist (m/w/x) Arbeitgeber: A.M.I. GmbH
A.M.I. GmbH bietet eine hervorragende Arbeitsumgebung für den Risk Management Lead im Bereich Medizintechnik in Feldkirch. Mit einem innovativen Ansatz zur Verbesserung der medizinischen Versorgung weltweit fördern wir eine offene und informelle Unternehmenskultur, die flache Hierarchien und enge Zusammenarbeit in kleinen Teams schätzt. Unsere Mitarbeiter profitieren von umfangreichen Weiterbildungsmöglichkeiten, einer modernen Cafeteria und kostenfreien Parkplätzen, was das Arbeiten bei uns nicht nur sinnvoll, sondern auch angenehm macht.
