Post-Market Surveillance Project Coordinator

Clinical Minnetonka, MN


We believe that great healthcare is an essential safeguard of human dignity.

At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.

We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

 

Who We’re Looking For:

As a key member of the Clinical Research team, the Post Market Surveillance Project Coordinator will play a pivotal role in ensuring the safety and efficacy of our medical devices throughout their lifecycle, while also providing valuable insights for future improvements. This individual will leverage their clinical expertise and project management skills to manage post-market surveillance and clinical evaluation activities globally across Laborie’s products, including driving continuous improvement initiatives. 

 

About the Role:

  • Manage post-market surveillance and clinical evaluation projects from initiation to completion including timeline development, resource allocation, and stakeholder communication 
  • Maintain accurate and comprehensive documentation of post-market surveillance and clinical evaluation activities, including reports, metrics and regulatory submissions 
  • Monitor and evaluate product performance and safety through post-market data, including adverse events, complaints, and product performance trends, to identify potential safety issues or areas of improvement 
  • Develops post-market surveillance and clinical evaluation processes and procedures, tools, and best practices 
  • Continuously review and improve post-market surveillance and clinical evaluation processes and procedures for efficiency and effectiveness 
  • Provide training and support to team members and other departments on post-market surveillance processes and regulations 

 

Minimum Qualifications:

  • Advanced degree in a related field (e.g., Nursing, Biology, Biomedical Engineering) and Minimum of 3 years of PMS experience 
  • Strong understanding of medical device regulations, including FDA and EU MDR requirements 
  • Experience in project management, including planning, execution, and monitoring of tasks and timelines 
  • Excellent analytical skills with the ability to interpret complex clinical and regulatory information 
  • Experience with evidence generation and technical writing 

 

 

Why Laborie:

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

  • Paid time off and paid volunteer time
  • Medical, Dental, Vision and Flexible Spending Account
  • Health Savings Account with Company Funded Contributions
  • 401k Retirement Plan with Company Match
  • Parental Leave and Adoption Services
  • Health and Wellness Programs and Events
  • Awarded 2023 Cigna Healthy Workforce Designation Gold Level

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.