Associate, Regulatory Projects

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...

OverviewAstraZeneca's Development Team is guided by a purpose to reimagine medicine, improving and extending people's lives.We are seeking key talent to join us in optimizing and strengthening our processes and ways of working. Our goal is to bring medicines to patients even faster, while investing in new technologies and building therapeutic area depth and...

Novartis is seeking a talented Senior Medical Device Development Leader to join our Global Device and Packaging Development team in Schaftenau, Austria. As an Associate Director Engineering, you will lead technical development and life-cycle management for innovative medical device products.About the RoleKey Responsibilities:Develop and implement device...

The Department of Public Finance (Prof. Dr. Florian Morath) at the University of Innsbruck is seeking to fill a position as a **Research Associate (Ph.D. position)** in the field of Applied Microeconomics, in particular Public Economics and Political Economy. - We offer:_ - A vibrant and dynamic research environment with a strong research focus on the...

Your Tasks- Coordination and implementation of labeling related tasks and projects - Improvement of labeling related processes - Organisation and maintenance of labeling related documentation and data files - Support preparation of regulatory submissions, license renewals and registrations to international authorities - Your Profile- Completed higher...

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...

Your Tasks - Conduct monitoring activities for clinical investigations - Generate monitoring plans and assist with completion of other clinical investigation documents - Ensure clinical investigations are conducted in accordance with the protocol, standard operating procedures, ISO14155, the Medical Device Regulation and all applicable regulatory...

**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...

Are you ready for the next career step or looking for a career change? As Team Leader, Electronics Design (M/F/d), a responsible field of activity awaits you in a 10-member team, which is responsible for the design and development of electronics and firmware in the R&D group Emerging Applications. The task of this group is the development of new product...

**Company**: Smart Santé Conseil supports health structures in their strategic, organizational or regulatory transformation projects. We are specialized in the health sector. Our Health Experts and Strategy Consultants work together on each of our projects, in order to respond most effectively to field issues. **Job**: - Evaluate the health of people and...

Your Tasks - Ensure compliance is in place for relevant security policies and procedures, including regulatory and legal requirements - Work with internal teams and third-party vendors to implement the relevant security policies and procedures, including regulatory and legal requirements - Provide consultation to IT projects on the testing, deployment,...

Your Tasks- Plan and develop clinical investigations on medical devices, ensuring compliance with regulatory requirements and company procedures - Oversee study activities, manage timelines, coordinate monitors, and work with clinical evaluation managers, data managers, and statisticians - Manage study documentation and regulatory submissions, maintaining...

We are seeking a Senior Technical Lead to join our team at Novartis Pharmaceutical Manufacturing GmbH in Schaftenau, Austria. As a key member of our Global Device and Packaging Development department, you will be responsible for leading technical development and life-cycle management in cross-functional teams.About the RoleAs Senior Technical Lead, your...

Your Tasks - Perform clinical research project management activities including resource planning, timelines, and milestone management - Coordinate and manage multicentric submissions to regulatory authorities and ethics committees, including writing, editing, compiling, and maintaining documents related to pre - and post-market clinical trials according to...

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...

**Main Tasks** - Global product management of cochlear implants throughout their complete life cycle - Support shaping future products - perform market research to uncover market trends, perform customer innovation research and discovery activities to uncover user needs, support the Research & Development during all the development phases of new products -...

Your Tasks - Global product management of cochlear implants throughout their complete life cycle - Support shaping future products - perform market research to uncover market trends, perform customer innovation research and discovery activities to uncover user needs, support the Research & Development during all the development phases of new products -...

Aufgaben - Analyze and interpret frame-by-frame data to identify potential risk factors in aseptic processing - Contribute to expanding and organizing our data library, ensuring accuracy and accessibility - Employ problem-solving skills to troubleshoot and resolve aseptic processing and simulation data issues - Maintain consistent and precise documentation...

Your Tasks - Global product management of cochlear implants and surgical systems, with focus on in-life management - Preparations for products market entry - support of trials activities, validate fit for market and operational readiness, provide input for regulatory strategy & approval - Support of launches & products in-life activities - launch, establish...

Your Tasks- Provide administrative support to the ISO - Assist in the process of gathering information on the current and future threat landscape, including but not limited to vulnerabilities, current threats, etc. - Creation and maintenance of documents, dashboards, presentations, and other means of communication to articulate information security...