Post Market Surveillance Analyst

2 weeks ago

Eden Prairie, Minnesota, United States Solventum Full time
Job Description:

Solventum is seeking a highly skilled Post Market Surveillance Analyst to join our team. As a key member of our regulatory affairs department, you will be responsible for leading document creation for Post Market Surveillance activities, including PMS Plans and review records. Your expertise in data analysis and reporting will enable you to identify emerging trends and escalate quality issues as necessary.

Key Responsibilities:
  • Lead cross-functional teams to gather data from multiple sources, including Complaints, Field Safety Actions, Risk Management, Non-conformances, and Validations.
  • Perform data analysis in applicable tools (Excel, Power BI, or similar applications) to detect emerging trends and escalate quality issues.
  • Partner with product functional areas to ensure Post Market Surveillance output is fed back into Research and Development, Design Quality, Supplier Quality, Risk Management, and Marketing.
  • Support responses for additional information requests received from competent authorities, registries, and notified bodies.
Requirements:
  • Bachelor's degree or higher from an accredited institution AND 3 years of experience in clinical research, medical safety, or post market regulatory affairs.
  • High School Diploma/GED AND 7 years of experience in clinical research, medical safety, or post market regulatory affairs.
  • 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.
Preferred Qualifications:
  • Degree in a field of science, such as Chemistry, Microbiology, Biology, Biochemistry, Engineering, or a related technical field.
  • Demonstrated success in project management, teaming, and influencing others to achieve results.
  • Experience in Regulatory Affairs or Quality role in the pharmaceutical, biological, or medical device industry.
  • Understanding of domestic and international requirements for post market surveillance, including ISO 13485/14971/20416, FDA Regulations (21 CFR 803, 806, etc.), CMDR, MDD, and EU MDR.
What We Offer:

Solventum offers a competitive compensation package, including a base salary range of $95,825 - $117,120, plus variable incentive pay, if eligible. We also offer a range of benefits, including Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and Retirement Benefits.

Solventum is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to maintaining the highest standards of integrity and professionalism in our recruitment process.

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