Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue.
Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit.
As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Job Description Post Market Surveillance Analyst 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives.
As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy.
Because at Solventum, we never stop solving for you. The Impact You’ll Make in this Role How You Will Make An Impact As a Post Market Surveillance Specialist you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.
Here, you will make an impact by:
• 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.
Your Skills And Expertise
To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:
• 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
AND In addition to the above requirements, the following are also required:
• Experience partnering with cross-functional teams to implement initiatives and processes in a global, matrixed environment.
Additional qualifications that could help you succeed even further in this role include:
• Bachelors degree in a scientific discipline such as Chemistry, Microbiology, Biology, Biochemistry, Engineering, or a technical field (preferred).
• 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
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