Senior Manager Post Market Surveillance

Together, we can beat cancer.

At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

If you want to be part of this important mission, we want to hear from you. 

This position leads Varian’s Post Market Surveillance (PMS) team. You will be responsible for maintaining the established processes for global compliance with applicable international PMS requirements. Managing a local and international team of both direct and indirect reports, you will ensure regulatory PMS timelines and requirements are met. You will identify improvement potentials, develop and implement solutions, and optimize interfaces and communication channels. A key interface with the various product and business groups within Varian, you will drive awareness of PMS requirements and signal and ensure PMS process compliance.

This position is part of the post-market surveillance (PMS) team supporting Varian’s ROS, MDO, and Brachy product lines. The role requires collaboration with relevant domestic and international business functions, leading cross-functional efforts, and ensuring PMS process compliance.

Responsibilities:

• Develop and maintain procedures and processes to investigate and analyze post market data to meet international requirements;
• Oversee collection, analysis and evaluation of information for PMS and trend reporting;
• Establish, maintain and refine PMS dashboards, information portals, and/or resources;
• Integrate technology into repetitive tasks, to optimize speed of processing and focus on clarity of analytics for signals and corresponding actions;
• Drive continuous improvement in corresponding processes and tools;
• Keep abreast of new or revised PMS regulations/guidelines and assess process impact;
• Create presentations summarizing major product quality issues and complaint trends;
• Provide data to cross-functional teams and stakeholder groups in support of product performance, regulatory, compliance and other product and safety focused deliverables/requirements;
• Provide support as needed during external and internal audits;
• Provide additional support as needed for Vigilance/AE/US MDR reporting, safety analysis and incoming data related to safety and complaints;
• Implement and maintain established PMS procedures.
• Create and maintain the product PMS plan, trend reporting, PMSR, and PSUR/SR.
• Monitor post-market signals/trends, utilizing statistical analysis techniques to investigate and gain insight into product performance.

• Review, analyze, interpret, and summarize PMS data; draw conclusions and make appropriate recommendations and decisions.
• Support cross-functional teams and stakeholder groups with ad-hoc post-market data analysis, data mining, and data queries to support product submission, regulatory compliance, and/or other product and safety-focused deliverables/requirements.
• Prepare responses and support vigilance reporting related to product safety and complaints.
• Establish and maintain PMS dashboards, information portals, and/or resources.
• Stay informed about new or revised PMS regulations/guidelines and assess process impact.

Requirements:

• BSc/MSc degree in Engineering, Mathematics, Statistics, or equivalent science-related field;.
• 3+ years of direct work experience in medical device quality functions (e.g., CAPA, complaint handling, submission, field action, etc.) is preferred;
• In-depth kKnowledge of FDA’s 21 CFR 820, 21 CFR 803, ISO 13485:2016, ISO 14971, MDD, EU MDR, Health Canada, as they pertain to PMS;.
• Intermediate to advanced experience of Excel, Minitab, or similar statistical software, and their targeted application to medical device PMS;
• Familiarity with database applications like QlikView, Power BI, Unity, Splunk, SAP, and MES;
• Proficient Proficiency in use of business tools like MS Office, Teams, Outlook, and Project;
• Organizational, time management and influencing skills essential for project work and coordinating activities within and across departments;Strong organizational, time management, and influence skills.
• Proficient written and communication skills with the ability to lead meetings;
• Motivated to learn and pick up new concepts quickly with the ability to thrive in a fast-paced, dynamic, and often ambiguous work environment;
• Ideally, prior team lead experience;
• Ideally, actively involved in manufacturer associations (e.g., COCIR, MEDTech Europe, ZVEI) regarding PMS activities.

Varian is required to comply with all local and applicable regulations that may be associated with vaccine requirements for certain roles.