Devops engineer m f d állások, munkák egészségügy, gyógyszeripar területen

Point of contact for Regulatory Affairs colleagues with focus on Latin America regarding product registrations, including guidance on responding to deficiency letters and regulatory authority inquiries...

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

as part of DFG sponsored project beginning in January 2026 limited for three years. The Title of the project is: EFFECTS OF LACTOBACILLUS REUTERI DSM 17938 ON THE ACUTE PSYCHOLOGICAL, ENDOCRINE AND IMMUNOLOGICAL STRESS RESPONSE IN HEALTHY CITY DWELLERS. Both preclinical and clinical data support...

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

Serve as the medical device subject matter expert to both internal and external customers for product development, risk assessment, training, implementation, literature reviews, complaints, safety signals, field action, voice of the customer, and voice of the business....

• 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

• 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

• 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

• 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.

• Support in maintaining and further developing Statista's ranking and rating databases, ensuring consistency, accuracy, and scalability
• Implement and optimize data pipelines (ETL/ELT) to automate data collection, transformation, and validation workflows

• Lead and support cross-functional projects in regulatory affairs and quality management.
• Identify, interpret, and implement regulatory requirements across global markets, with a strong focus on international registrations outside the U.S. and EU.

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...

• Conduct studies on extractables and leachables from medical devices, including evaluation, interpretation, and documentation of results
• Identify and characterize potential extractables and leachables using internal and external databases

• 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

KOL Engagement: Build and nurture strong relationships with key opinion leaders and healthcare professionals to support clinical development, product launches, and medical education. Represent the company at key industry events to expand our scientific influence....