It security engineer m f d állások, munkák minőségbiztosítás kategóriában

• 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).

• 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.

• Regulatory assessment of raw materials, recipes and nutrient profiles
• Creation and updating of regulatory documentation (e.g. list of ingredients, nutrition information, raw material information)
• Review and approval of labels and communication materials in accordance with EU food law

• 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

• Start Date:or
• Latest Possible Start:
• Duration: 6 months initially; extension possible (e.g., additional 6 months)
• Location: Basel
• Workload: 100%
• Home Office: Yes
• Travel: Not expected
• Team Size: PCS safety team approx. 6; cross-functional project teamsmembers
• Hiring Manager: Simone Melega

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....

• 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