Devops engineer m f d állás, munka

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

• 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.

• 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

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...

• 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.

• Market development in alignment with the Commercial Operations team
• Developing and conducting product trainings (online and classroom)
• Participation in product launch activities
• Answering questions from the local sales and service organizations
• Support on customer visits, exhibitions and congresses

• 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