Clinical Scientist

Clinical Scientist / Post Market Quality Specialist Location : Texas (only W2)We are looking for an experienced Clinical Scientist / Post Market Quality Specialist to support post-market quality activities for medical device products. In this role, you will lead data-driven evaluations of product performance in the field and ensure compliance with global regulatory and quality standards.Key Responsibilities• Perform statistical analysis of complaint and post-market data to identify trends and potential product risks• Lead and coordinate Post Market Surveillance Review Board (PMSRB) meetings• Prepare and manage key post-market surveillance documentation, including PSURs, PMS Reports, and PMCF documentation• Conduct and support moderate to complex product investigations and identify unacceptable field trends• Ensure appropriate corrective and preventive actions (CAPA) are implemented when required• Provide clinical data insights to support benefit-risk assessments and regulatory submissionsQualifications• Bachelor’s degree in Engineering or a related field• 5+ years of experience in post-market quality, preferably within the medical device industry• Strong understanding of FDA regulations, ISO 13485, ISO 14971, and EU MDR• Experience with statistical analysis and complaint trend evaluation• Ability to work cross-functionally with quality, clinical, and regulatory teamsRecruiter | S4 AnalyticsPlease feel free to reach me at + 1(469)-429-8065Pavan@s4analytix.com