Senior kontroller állások, munkák klinikai kutató kategóriában

• Lead and oversee all clinical safety and vigilance processes for medical devices.
• Manage adverse event assessment and reporting in compliance with global regulations.
• Ensure accurate development and maintenance of RSI, CIP, and IB safety content.

Medical Device Clinical Safety Scientist (m/f/d)- Healthcare/ Scientific/ Biomedical/ MDs/ MD Clinical Investigation/ CIP/ Protocol/ IB/ RSI/ Risk Management/ ISO/ Drug/ English PROJECT: For our customer a big pharmaceutical company in Basel, we are looking for a Medical Device Clinical Safety...

Provide expert leadership and oversight for all clinical safety and vigilance activities associated with Class II and/or III Medical Devices (MD), ensuring adherence to global regulatory requirements and internal standards throughout the product lifecycle....

• 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

• Collect data and prepare progress reports, KPIs, and metrics for regional and global reporting, including monthly reports, management reviews, and quarterly quality reports.
• Support ad hoc global quality reporting by gathering data and providing contextual insights to regional QA Senior Management.

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...