Regulatory Affairs Medical Device Manager

**Summary**: **About the Role**: **Major accountabilities**: - You will support the global Medical Device & Precision Medicine regulatory strategy with a focus on innovation, maximizing business benefit balanced with regulatory compliance. - Lead, support and implement all global Regulatory Affairs Medical Device (RA MD) submission activities for assigned...

**Summary**: LOCATION: Schaftenau, TYPE: Hybrid Working, #LI Hybrid Are you looking for a challenging and rewarding career in Combination Product Development with a brand new device ? Do you want to be part of a team of talented and passionate engineers and scientists who are responsible for the development of parenteral combination products to ensure that...

**Summary**: **About the Role**: - As Medical Device Technical Transfer Lead (Associate Director Science & Technology) you will be managing the successful transfer of medical device assembly and packaging processes from development phase into commercial operations. This will allow our organization to excel in the launch of smartly developed and competitive...

**Summary**: **About the Role**: **Major accountabilities**: - Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance. - Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. - Identify the...

**Summary**: LOCATION: Schaftenau, TYPE: Hybrid Working, #LI Hybrid Are you looking for a challenging and rewarding career in Combination Product Development with a brand new device? Do you want to be part of a team of talented and passionate engineers and scientists who are responsible for the development of parenteral combination products to ensure that...

**Summary**: **About the Role**: **Major accountabilities**: - Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for XXX modality projects/products. - Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for...

**Summary**: **About the Role**: **Major accountabilities**: - Formulate, lead and drive global CMC regulatory strategy for XXX modality pro-jects/products drawing on substantial regulatory expertise with a focus on innovation, maxim-izing the business benefit balanced with regulatory risks and compliance. - Identify the required documentation and any...

394730BR **Senior Expert - Device Project Analyst (f/m/d)**: Austria **About the role** **Location: Schaftenau, Austria, Hybrid Working #LI-Hybrid** **About the Role**: **Key Responsibilities**: Your responsibilities include, but are not limited to: - As member of global CMC analytical sub team and device sub team for your project(s) you are contact...

**Summary**: **About the Role**: **Key Responsibilities**: Your responsibilities include, but are not limited to: - As member of global CMC analytical sub team and device sub team for your project(s) you are contact person & coordinator for all project-specific analytical tasks related to functional attributes of drug-device combination products at all...

**Summary**: In 2014 the first medical device was introduced to the market by Novartis/Sandoz, since then the portfolio for medical devices and combination products are heavily growing. Be part of the QA Medical device team and support commercialization of new devices to the markets worldwide. As part of our team, you will be supporting introduction of new...

393585BR **QA Operations Expert**: Austria **About the role** **Location**: Novartis, Schaftenau, Austria **About the Role**: In 2014 the first medical device was introduced to the market by Novartis/Sandoz, since then the portfolio for medical devices and combination products are heavily growing. Be part of the QA Medical device team and support...

**Summary**: LOCATION: Schaftenau, Austria TYPE: Intern Position, Fixed Term 74! The number of medical device projects in Novartis. Without a safe, user friendly, high-quality drug delivery system our patients cannot take their medicine. The Compliance, Systems and Operations team in Basel needs you to accelerate one of the most diverse and innovative...

**Summary**: Are you looking for a challenging and rewarding career in pharmaceutical packaging development? Do you want to lead a team of talented and passionate packaging engineers and scientists who are responsible for the development of parenteral packaging containers and combination products to ensure that our delivery systems fulfill the highest...

**Summary**: **About the Role**: **Key Responsibilities**: - Own and run packaging design for secondary & tertiary packaging activities (incl. labelling) in global cross functional teams to launch new products and redesign on market products. - Lead packaging design projects for technology platforms and manage collaboration with involved functions to ensure...

387779BR **Associate Director Science & Technology (f/m/d)**: Austria **About the role** **About the role** The global Technical Transfer team supports the development and launch of one of the most diverse and innovative portfolios in the pharma industry. By managing successfully the transfer of device assembly and packaging processes from development...

**Summary**: Supporting product registration and maintenance throughout the product life cycle by aligning regulatory strategies and reviewing documents related to CMC (Chemistry, Manufacturing & Control). This applies to site specific (global and local) products and is intended to ensure timely market supply in compliance with regulatory requirements....

**Summary**: As Senior QA Compliance Expert you will support, facilitate and drive on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the Campus products to ensure timely supply to the markets in compliance with current regulatory obligations and...

**Summary**: Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients...

**Summary**: We are looking for a highly skilled and experienced laboratory professional who contributes to the Good Laboratory Practice by ensuring efficient and timely review of laboratory analyses, compliance to industrial standards, investigation of deviations and complaints, training of personnel and coordination of device maintenance. **About the...

**Summary**: Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities - all to bring our medicines to patients...