Sr Dir Postmarket Surveillance

• Responsible for long term strategy to assure product quality and maintaining alignment to B. Braun North American Company objectives.
• Facilitates the execution of post market surveillance of medical devices, pharmaceutical and combination products.
• Ensures consistent execution of the complaint management system and regulatory reporting process for products manufactured by and imported by B. Braun North American Companies.
• Creates and maintains a system for identifying, monitoring and trending key product quality attributes across quality data sources to identify and manage risk.
• Facilitates all post market product risk management activities (i.e. health risk analysis/health hazard assessments) including escalation to Recall Committee.
• Accountable for management of the Recall Committee process with full responsibility for meeting facilitation and decision outcomes in a timely manner and for timely and effective execution of recalls and other post-market actions.
• Responsible for the development, harmonization, maintenance, and continuous improvement of the risk management system and statistical techniques for pharmaceutical, medical devices, and combination products.
• Utilizes data to drive product quality excellence across all B. Braun North American Companies and ensure closed loop feedback to Corrective and Preventive Actions (CAPA) and Quality Management Review.
• Acts as champion to identify top product and process quality and safety risks and leads efforts for improvement
• Responsible for personnel actions including hiring, performance management, termination.
• The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Education and Professional Knowledge: Bachelor's degree required, Master's degree preferred.

Experience: 10-15 years related experience, plus a minimum of 5 years management experience required.

Knowledge and Skills Requirements: Requires breadth of organizational, professional field, and industry knowledge. Ability to integrate critical information from several diverse areas. Champions advanced strategies and concepts.

PI279398978