Senior Post Market Surveillance Analyst

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 is part of Varian’s Post Market Surveillance (PMS) team. The role requires collaboration with relevant local and international business functions, leading cross-functional efforts, and ensuring PMS process compliance.

Responsibilities:

• Implement and maintain established PMS procedures;
• Create and maintain device PMS plans, trend analysis and associated reports;
• 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;
• 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;
• Minimum of 4 years of direct work experience in medical device quality functions (e.g., CAPA, complaint handling, submission, field action, etc.) is preferred;
• Knowledge 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;
• Familiarity with database applications like QlikView, Power BI, Unity, Splunk, SAP, and MES;
• Proficiency in use of business tools like MS Office, Teams, Outlook, and Project;
• 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.

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