Devops engineer m f d állások Németországban (egészségügy, gyógyszeripar)

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...

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....

• 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

• 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....

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

• Develop and execute strategic and operational roadmaps for the Latin American market.
• Establish and expand a profitable distributor network, opening new markets and finding new business partners.

• Planning and initiation of business cases, definition of the project scope, objectives and deliverables. This includes gathering requirements, assessing feasibility and developing a project plan that aligns with organizational goals
• Monitoring of timelines and budget