Leads document creation for Post Market Surveillance activities including PMS Plans and review (PMS report/PSUR) records.
Responsible for compiling data and preparing reports at periodic intervals as required by regulations.
Leading the cross-functional team responsible for gathering data from multiple sources including Complaints, Field Safety Actions, Risk Management, Non-conformances and Validations for reporting.
Perform required data analysis in applicable tools (Excel, Power BI or similar applications) to detect emerging trends of such issues that may require action and escalation to Senior Leadership.
Partnering product functional areas to ensure that Post Market Surveillance output is fed back into Research and Development, Design Quality, Supplier Quality, Risk Management and Marketing to achieve a closed-loop process.
Supports responses to additional information requests received from competent authorities, registries and notified bodies.
Identification and escalation of quality issues as necessary.

Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution and 2 years of experience in clinical research, medical safety or post market regulatory affairs in a private, public, government or military environment OR High School Diploma/GED AND 6 years of experience in clinical research, medical safety or post market regulatory affairs in a private, public, government or military environment
Experience partnering with cross-functional teams to implement initiatives and processes in a global, matrixed environment
Experience in project management, including cross-functional collaboration and influencing stakeholders to achieve results (e.g., Lean Six Sigma Black Belt/Green Belt, PMP certification)
Knowledge of domestic and international post-market surveillance requirements, including ISO 13485, ISO 14971, ISO 20416, FDA regulations (21 CFR 803, 806, etc.), CMDR, MDD, and EU MDR
Experience analyzing data from sources such as product complaints, clinical studies, and competitive products, including the use of data analysis tools (e.g., Power BI or similar platforms)
Proficiency with Microsoft Office applications including Word, Excel and PowerPoint.
Strong written and verbal communication skills, with demonstrated problem-solving and analytical thinking abilities, and the ability to manage multiple priorities effectively in a fast-paced environment while maintaining strong organizational skills and attention to detail.

Post Market Surveillance Analyst

Key skills