Post Market Surveillance Analyst

Position Description

Job Title
Post Market Surveillance Analyst

Collaborate with Innovative 3Mers Around the World

Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with 96,000 other curious, creative 3Mers.

“At 3M, thanks to our culture where people feel like they belong, can grow and are appreciated, we are more than the sum of our parts. Our different perspectives and experiences help us solve some of the world’s toughest challenges together.” – Zoe Dickson, executive vice president and chief Human Resources officer at 3M

This position provides an opportunity to transition from other private, public, government or military environments to a 3M career.

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 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, 3M requires (at a minimum) the following qualifications:

• Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution
• Three (3) years of experience in clinical research, medical safety or post market regulatory affairs in a private, public, government or military environment.
• Three (3) years of experience collaborating cross functionally to drive key initiatives or processes in a global, matrixed organization in a private, public, government or military environment.

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 other related technical field is preferred.
• Demonstrated success in project management, teaming and influencing others to achieve results (i.e. Black Belt /Green Belt / PMP certification).
• Experience in a Regulatory Affairs or Quality role in pharmaceutical, biological or medical device industry in a private, public, government or military environment.
• Understanding of the domestic and international requirements for post market surveillance such as ISO 13485/14971, FDA Regulations (21 CFR (803, 806, etc.), CMDR, MDD and EU MDR.
• Good written and verbal communication, problem solving and applied thinking skills.
• Well organized and able to multitask effectively.
• Proficiency with Microsoft Office applications including Word, Excel, and PowerPoint.
• Experience analyzing data such as product complaints, clinical studies, and competitive products using Power BI or other statistical tools including charting and pivot tables.

Travel: May include up to 5% domestic

Relocation Assistance: Is not authorized

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being 

3M offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope. 

Resources for You 

For more details on what happens before, during and after the interview process, check out the Insights for Candidates page at 3M.com/careers.