Post Market Surveillance Analyst

Job Description

Join Solventum as a Post Market Surveillance Analyst and contribute to improving healthcare outcomes. Lead the creation of documentation for post-market surveillance activities, including PMS Plans and review records (PMS report/PSUR). Compile data and prepare reports at periodic intervals as required by regulations. Lead 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 data analysis in Excel, Power BI, or similar to detect emerging trends and escalate to Senior Leadership. Partner with product functional areas to ensure post-market surveillance output feeds back into Research and Development, Design Quality, Supplier Quality, Risk Management, and Marketing. Support responses to additional information requests from competent authorities and notified bodies. Identify and escalate quality issues as needed.

Qualifications

1. Bachelor’s degree or higher from an accredited institution and 2 years of experience in clinical research, medical safety, or post-market regulatory affairs, OR High School Diploma/GED AND 6 years of experience in clinical research, medical safety, or post-market regulatory affairs. 2. Experience partnering with cross-functional teams to implement initiatives and processes in a global, matrixed environment. 3. Experience in project management, including cross-functional collaboration and influencing stakeholders to achieve results. 4. 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. 5. Experience analyzing data from sources such as product complaints, clinical studies, and competitive products, including the use of data analysis tools. 6. Proficiency with Microsoft Office applications including Word, Excel, and PowerPoint. 7. Strong written and verbal communication skills, problem-solving, analytical thinking abilities, and the ability to manage multiple priorities effectively.

Benefits

- Medical, Dental & Vision - Health Savings Accounts - Health Care & Dependent Care Flexible Spending Accounts - Disability Benefits - Life Insurance - Voluntary Benefits - Paid Absences - Retirement Benefits