Regulatory Affairs Associate

Job SummaryWe are seeking a highly skilled Regulatory Affairs Associate to join our team at MED-EL. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key ResponsibilitiesRegulatory Dossier Compilation and Submission: Compile and submit regulatory dossiers to relevant...

Position OverviewThe Regulatory Affairs Associate will be responsible for the comprehensive management of regulatory submissions and documentation. This role involves the development of submission strategies and the assessment of regulatory requirements to ensure compliance with industry standards.Key ResponsibilitiesCompilation and Submission: Prepare and...

Position OverviewThe role involves comprehensive management of regulatory submissions and dossier preparation. You will be responsible for developing submission strategies and conducting thorough regulatory assessments.Key ResponsibilitiesCompilation and Submission: Prepare and submit regulatory dossiers efficiently.Strategic Development: Formulate...

About MED-EL Medical ElectronicsMED-EL is a prominent manufacturer dedicated to creating innovative medical devices aimed at addressing various forms and levels of hearing impairment.Our ImpactOur distinctive range of implantable hearing solutions positively impacts the lives of thousands of individuals across more than 140 countries globally.Company...

About MED-EL Medical ElectronicsMED-EL is a prominent manufacturer dedicated to pioneering medical devices aimed at addressing various forms and severities of hearing impairment.Our MissionOur exceptional range of implantable hearing solutions has positively impacted the lives of countless individuals across more than 140 nations globally.Company...

About the RoleKey Responsibilities:Develop and execute global CMC regulatory strategies for Biologics or Small Molecules projects/products, leveraging extensive regulatory expertise to drive innovation and minimize risks.Lead global CMC submission activities, including planning, authoring, reviewing, coordination, and submission, ensuring seamless execution...

About MED-EL Medical ElectronicsMED-EL is a prominent developer of cutting-edge medical technologies aimed at addressing various forms of hearing impairment. Our distinctive range of implantable auditory solutions has positively impacted the lives of countless individuals across more than 140 nations globally. With our main office located in Innsbruck,...

About MED-EL Medical ElectronicsMED-EL is a prominent producer of cutting-edge medical technologies aimed at addressing various forms and levels of hearing impairment. Our distinctive range of implantable auditory solutions serves countless individuals across more than 140 nations globally. With our headquarters located in Innsbruck, Austria, MED-EL employs...

About MED-EL Medical ElectronicsMED-EL is a prominent developer of advanced medical technologies aimed at addressing various levels of hearing impairment. Our exceptional range of implantable auditory solutions positively impacts the lives of countless individuals across more than 140 nations globally. With our main office located in Innsbruck, Austria,...

Company Overview: MED-EL Medical Electronics is a prominent developer of advanced medical technologies aimed at addressing various forms of hearing impairment. About the Role: As a Regulatory Affairs Specialist, you will play a crucial role in ensuring that our innovative implantable hearing solutions meet the necessary regulatory standards across multiple...

About X-Therma GmbHX-Therma GmbH is a pioneering startup in the medical technology sector, driven by innovation and a passion for improving healthcare outcomes. Our mission is to develop cutting-edge solutions for the storage and transportation of medical products, enabling global access to life-saving treatments.Job SummaryWe are seeking a highly skilled...

Leonhard Lang GmbH Präsenz / Mobil Berufserfahrung (Senior Level) Qualitätsmanagement, Qualitätssicherung Vollzeit Jahresgehalt: 53.200 EUR **WIR SETZEN IMPULSE**: - Seit 1983 entwickelt, produziert und vertreibt Leonhard Lang Medizinprodukte, wie Elektrodensysteme und Zubehör für EKG, Elektrochirurgie, Defibrillation, Stimulation sowie Gele und...

Your Tasks- Responsible for multiple aspects of office management for the Regulatory Affairs Department - Management of informational lists and databases - Certificate ordering and legalization - Sales area communications - General regulatory submission support - Your Profile- Written and verbal fluency in English - Attention to detail and excellent...

Wir sind international und Landwirtschaft ist unsere Leidenschaft. Unser Familienunternehmen produziert und vertreibt unter eigenen Marken hochwertige Produkte für naturverbundene Menschen und Landwirte weltweit. Dafür brauchen wir motivierte Mitarbeiter, die wir langfristig fördern. Für die Unterstützung unseres R&D Teams am Firmensitz Innsbruck...

Your Tasks- Regulatory dossier compilation and submission - Regulatory assessment and submission strategy development - Regulatory itelligence gathering - Management of informational lists and databases - Sales area communications - Your Profile- Written and verbal fluency in English - Attention to detail and excellent organizational skills - Strong...

Regulatory dossier compilation and submission Regulatory assessment and submission strategy development Regulatory itelligence gathering Management of informational lists and databases Sales area communications Your Profile Written and verbal fluency in English Proficient using PC and MS applications software Attention to detail and...

Your Tasks- Operational handling of international tenders in the medical device sector - Elaboration and timely compilation of all relevant proposal/tender documents - Communication and coordination with the responsible departments in the company (product management, regulatory affairs, logistics, R&D, sales, etc.) - Review and control of all agreements and...

MED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousands of individuals in more than 140 countries worldwide. With headquarters in Innsbruck, Austria, MED-EL has over 2,800 employees around the world. RA_ Post-Market...

X-Therma is a fast-moving and innovative startup from San Francisco with an office and hardware R&D branch in Innsbruck, Austria. We are developing breakthrough technology to improve modern medicine and save billions of lives. With our subzero storage and transport solutions, we are enabling global access to organ transplants as well as cell and gene therapy...

X-Therma is a fast-moving and innovative startup from San Francisco with an office and hardware R&D branch in Innsbruck, Austria. We are developing breakthrough technology to improve modern medicine and save billions of lives. With our subzero storage and transport solutions, we are enabling global access to organ transplants as well as cell and gene therapy...

As an important part of a small team, you will have the opportunity to support our company on its way to quality excellence. Through your meticulous and accurate way of working, you will own the product documentation structure and you will be responsible for creating comprehensive and understandable documentation. In your role, you will form an essential...

**Role Description**: As an important part of a small team, you will have the opportunity to support our company on its way to quality excellence. Through your meticulous and accurate way of working, you will own the product documentation structure and you will be responsible for creating comprehensive and understandable documentation. In your role, you will...