3 engineering specialist jobs found

CSL This is an entry level position into Quality Assurance Operations. Developing responsibilities include assisting with investigating deviations, relevant to area of responsibility. Responsible for driving continuous improvement on production floor to ensure compliance to cGMPs. Real time review of batch records, including critical processing steps with production floor presence. Responsibilities: Responsible for assisting with investigating deviations relevant to area of responsibility. Responsible for participating in investigation meetings with responsible department and any required support groups. Responsible for participating in necessary research to determine root cause, corrective/preventative actions, product disposition, and using the investigation tools provided by QAO Management. Collaborate with manufacturing personnel to perform root cause analysis at time deviation occurs and assist in determining robust corrective/preventive actions. On-call for...

CSL The Lead, Global Regulatory Affairs Device is responsible for: Developing, coordinating and implementing global Software as a Medical Device regulatory strategies for new combination and standalone medical devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with regulatory agencies. This role promotes strong cross-functional collaboration and effective communication across Global Operations, Plasma Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to...

CSL The Lead, Global Regulatory Affairs Device is responsible for: Partnering closely with R&D, Manufacturing, Operations, Quality, and Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving device regulatory and compliance requirements for plasmapheresis devices, drug device combination products, standalone drug delivery devices, and ancillary devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with...