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20 Varian Medical Systems International India Jobs
Post Market Surveillance Analyst
4-9 years
Pune
1 vacancy
Post Market Surveillance Analyst
Varian Medical Systems International India
posted 1d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- 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.
- 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 (eg, 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.
Employment Type: Full Time, Permanent
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