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36 jobs found
17.05.2025
WP
West Pharma Senior Specialist Regulatory Affairs United States, Pennsylvania, West Whiteland Township
Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant...
Complete the quarterly financial forecast and annual budget for the quality and procurement functions using BPC, proactively identifying financial risks and opportunities. Use SAP to gather, analyze, and interpret financial...
Site QA Manager designee for QA Systems and customer engagement activities. Prioritize & manage available QA systems resources to ensure on time scheduling and response timelines are achieved for customer...
Maintain and support existing tooling. Participate in new mold design reviews. Monitor preventative maintenance schedules. Work with the local Tooling Engineers participating in factory acceptance trials and site acceptance trials....
Coordination of product transfers between West plants including documentation, coordination of trials and round robin studies, root cause analysis in case of differences detected. Initiating, Leading/ Supporting projects (Quality improvement,...
Perform activities for creation, issuance and review of customer notifications relating to West change controls. Coordinate customer notification process across cross functional teams, which includes direct communication with change owners...
Is proficient in the use and maintenance of laboratory test equipment necessary for conducting root-cause investigations; such as Instron, CT scanner, oscilloscope, power supply, multi-meter, microscopes. Is proficient in the...
Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant...
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