Devops engineer m f d állás, munka

Provide strategic statistical consultation and hands-on implementation of advanced methodologies to optimize clinical trial designs and data analytics;...

• Develop and validate LC-MS methods for the quantification of impurities in complex samples
• Optimize and troubleshoot analytical methods to ensure accuracy, precision and robustness 
• Collaborate closely with cross-functional teams to drive project success

• Developing and maintaining sterility assurance and contamination control strategies for aseptic processing
• Leading risk assessments for aseptic process, single use systems and critical interventions, and ensuring compliance with authorities relevant Guidance such as Annex 1

• Drive regulatory strategy for new product launches, ensuring proactive and effective planning aligned with global requirements
• Lead a team of regulatory experts in External Devices & Software within Regulatory Affairs

• Perform release and stability testing of antibodies, proteins, and peptides using capillary electrophoresis techniques (e.g. CE-SDS, cIEF, CZE) in a GMP-compliant laboratory
• Conduct analytical method validations
• Document all work accurately in LIMS, Chromeleon and on paper

• Support MED-EL rehabilitation services world-wide
• Provide content and manage the hearing rehabilitation portfolio
• Develop and promote rehabilitation materials, tools, programs, and services for various platforms and media

• You ensure that each batch is manufactured and tested in accordance with legal regulations
• You approve or reject bulk and finished products and sign the corresponding test protocols
• You approve specifications, sampling instructions, and testing instructions and ensure compliance with them

• Lead complex, data-driven engagements with international healthcare stakeholders
• Design and own project frameworks, KPI models, scoring methodologies, and implementation roadmaps in close collaboration with the Analysis and Data Science teams

• Responsible for the functionality, data quality, compliance, and user-friendliness of RIMS and eCTD systems.
• Ensuring the operation, maintenance and further development of the systems (Extedo eCTDmanager, Veeva RIM).

• Supporting system-related inquiries by analyzing and evaluating system errors and user requests for improvements and implementing solutions in collaboration with IT teams.
• Creating and revising work instructions.

Contribute to the design and content development of training modules on relevant Donor Recruitment topics, creating training plans in collaboration with all relevant interfaces and stakeholders...

• Product Management for electric-acoustic solutions and related objective measures
• End-to-end product lifestyle management: from requirements gathering and development support to launch activities and in-life management
• Delivery of presentations and training for employees, professionals, and recipients

Research in the Martins lab aims at understanding the mechanisms regulating early T lymphocyte development and T lymphocyte malignancies. Normal T lymphocyte development relies on the import of hematopoietic progenitors that originate in the bone marrow and seed the thymus. There, these progenitors...

• Conduct independent literature and therapy research on Functional Electrical Stimulation (FES) for various indications
• Coordinate and manage study projects in close collaboration with internal departments and the BU management

• Performing post-market surveillance and vigilance activities in accordance with internal procedures and applicable regulations
• Coordination of recalls and field actions as well as establishing and maintaining quality system related workflows, processes and procedures

• Lead and deliver workstreams within international healthcare benchmarking and transformation projects
• Co-develop project methodologies, KPI frameworks, and scoring logic in close coordination with the Analysis and Data Science teams