Post Market Surveillance Analyst

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

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.

Who we are: We are a team of more than 73,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Healthineers’ specific businesses, please visit our company page here.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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