Senior regulatory reporting associate állás, munka

• Support planning, tracking, and assembling regulatory content for simple submissions
• Manage operational tasks such as document retrieval, submission creation, and delivery
• Coordinate with global teams to maintain timelines and compliance

Develop and implement DSS cross-functional technology infrastructure strategy, ensuring alignment with business needs and stakeholder engagement, including Clinical Data Science, Data Engineering, Statistical Programming and Biostatistics...

• Responsible for processing incoming complaints in accordance with applicable process specifications
• Independent processing and assessment of complex or critical complaint cases with potentially high risk to patient safety or regulatory compliance

• 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

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

• 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

• Lead Scientific Discovery 
• Drive independent programs to identify novel plant species with untapped potential for PhytoComplex development 
• Establish innovative analytical methodologies for characterizing complex bioactive compounds using advanced techniques including chromatography and spectroscopy 

• Contribute to all phases of medical device development, from architecture concepts to design verification and design transfer
• Design and develop low-power medical embedded systems, with a strong focus on safety, reliability and regulatory compliance (IEC13485, IEC60601, ISOetc.)