Post Market Surveillance Analyst

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. 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:

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
 

As a Post Market Surveillance Analyst 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 with 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 for 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 3 years of experience in clinical research, medical safety or post market regulatory affairs in a private, public, government or military environment
• High School Diploma/GED AND 7 years of experience in clinical research, medical safety or post market regulatory affairs in a private, public, government or military environment
• Proficiency with Microsoft Office applications including Word, Excel and PowerPoint.
• Experience collaborating cross functionally to drive key initiatives or processes in a global, matrixed organization.

Additional qualifications that could help you succeed even further in this role include:

• Degree in field of science such as Chemistry, Microbiology, Biology, Biochemistry, Engineering or related technical field is preferred.
• Demonstrated success in project management, teaming and influencing others to achieve results (Black belt, Green belt, PMP certification).
• Experience in Regulatory Affairs or Quality role in pharmaceutical, biological or medical device industry in a private, public, government or miliary environment.
• Understanding of the domestic and international requirements for post market surveillance such as ISO 13485/14971/20416, FDA Regulations (21 CFR (803, 806, etc.), CMDR, MDD and EU MDR.
• Experience analyzing data such as product complaints, clinical studies and competitive products using Power
• Proficiency with Microsoft Office applications including Word, Excel and PowerPoint.
• Good written and verbal communication, problem sol