Senior Manager, Post Market Compliance

Requisition ID:  31747  

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. 

The Post Market Compliance Senior Manager will oversee all aspects of the Post Market processes, including Complaint Handling / AER, Field Actions, and Periodic Reporting. This involves leading a global team ensuring compliant Global processes by staying abreast of regulatory expectations and industry best practices, facilitating a Global Center of Excellence with extended stakeholders, and owning the Global policies and tools.  This team will also be executing to these Global processes and procedures and coordinating execution activities with the factories and regions.  This person will work extensively with stakeholder departments such as Commercial, Operations, Service, Clinical, Medical Affairs and Regulatory on Post Market Surveillance strategy and execution.

As the global post market compliance leader and subject matter expert, the incumbent works closely with cross-functional quality and organizational leaders to drive continuous state of audit readiness.  Provides inspirational guidance, bringing out the best in associates by instilling a bias for customer impact, data-driven results, commitment to excellence, and a collaborative, high-performing culture focused on continuous improvement and compliance.  Develops and maintains exceptional internal and external relationships with stakeholders and regulatory agencies, regularly monitoring the external landscape as it relates to the Company’s long-term business objectives.  Ensures all quality activities are in accordance with applicable laws, rules and regulations of the intended markets meeting the highest quality standards and customer expectations.

DUTIES AND RESPONSIBILITIES

• Serve as subject matter expert in Post Market compliance (complaint handling / AER, field actions, post market surveillance reporting). 
• Act as primary point of contact for audits / inspections (regulatory, customer, notified body) in these areas.
• Accountable to ensure that all the complaints (including high priority complaints) are processed in a timely manner that keeps the organization in good regulatory standing.
• Stay abreast of internal and external stakeholder requirements to efficiently deliver compliant processes which also deliver business and customer benefit.
• Lead a sizeable Global team working together on these shared QMS processes.  Must be sensitive to cross-cultural considerations and flexible in working styles and times.
• Partner closely with Quality leaders in factories and regions on end-to-end process delivery.
• Partner closely with key stakeholders inside and outside of Quality (service, commercial, regulatory) to develop and maintain efficient and compliant processes to serve internal and external customers.
• Monitor the emerging intelligent automation landscape (AI, Robotic Process Automation, Augmented Reality among others) and deploy solutions that would drive productivity improvements.
• Serve on project teams to ensure Post Market considerations are considered.
• Ensures that the Quality Management System is established, implemented and maintained for effectiveness in accordance with applicable standards within scope of Quality Manual (including but not limited to ISO 13485, MDR, MDSAP, FDA Quality System Regulations).  
• Develop, monitor, and report KPI’s related to process efficiency and performance.  Proactively detect emerging issues and drive continuous improvement.
• Manage personnel and all associated activities of the Post Market Compliance group including managing performance and developing talent.
• Assess and define department training needs. Confirm all training needs are met, and training is completed within the expected timeframesteam responsible for complaint intake, investigation, risk assessment, AER / MDR reporting, customer communication
• Ensure complaints are processed in timely and accurate manner and all reporting requirements are met.
• Lead team responsible for the Field Action determin