Senior regulatory reporting associate állások Svájcban (egészségügy, gyógyszeripar)

For our partner located in the canton of Bern, GI Life Sciences is looking for a: SENIOR SCIENTIST BIO-/CHEMICAL QUALITY CONTROL Start : Mid-November End : YOUR MISSION : As a SENIOR SCIENTIST IN BIO-/CHEMICAL QUALITY CONTROL, you will play a key role in establishing the BCQC unit within the...

• 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

• Market & Revenue Development: Implement market entry strategies and acquire international patients (B2C) as well as strategic partners (B2B)
• Market Analysis: Conduct market research, evaluate opportunities, and assess regulatory and competitive landscapes

• Design, develop, and optimize coagulation diagnostic assays and reagents
• Lead feasibility studies, verification, and validation activities in compliance with ISOand IVDR requirements
• Document all activities according to quality system procedures and design control standards

• 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.)