Post-Market Surveillance Associate
4 weeks ago
Vantive: Revolutionizing Kidney Care
Baxter is on a journey to separate its ~$5B Kidney Care segment into a standalone company. Vantive will build on the company's nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to patients worldwide.
At Vantive, you will become part of a community of professionals who are focused, courageous, and driven to improve patients' lives. The Post-Market Surveillance Associate will be responsible for evaluating potential product quality complaints, initiating timely actions, and ensuring applicable regulatory requirements are met.
Key Responsibilities:
- Evaluate potential product quality complaints and initiate applicable records and actions within the proper Quality System.
- Own and process quality complaints as per applicable procedures.
- Determine, facilitate, and/or approve reportability assessments and decisions based on applicable procedures.
- Author and submit applicable regulatory reports to competent authorities when deemed required.
- Monitor the status and progression of complaints under investigation and initiate actions to facilitate resolution and closure.
- Review and approve the results of Engineering, Manufacturing, Quality, Service, and/or Supplier evaluations and investigations of complaints.
- Perform queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints to drive continuous improvements within the department and organization.
- Implement and maintain Post-Market Surveillance documents as per EU Medical Device Regulation.
Requirements:
- Excellent verbal and written communication skills.
- Analytical approach to problem-solving.
- Ability to handle and manage workload independently.
- Well-organized and able to multitask effectively in a rapid-paced environment.
- Experience with Trackwise or equivalent complaint tracking system software and Microsoft Office and database skills are required.
- Knowledge of FDA/ISO regulations and Country requirements.
- Knowledge of MDR and MDV reporting.
Education and/or Experience:
- Bachelor's Degree – Preferred: engineering, nursing, biomedical, life science, or equivalent (S.T.E.M.).
- Prior experience (2+ years) with Regulatory, Quality, Compliance, or a combination of technical experience such as analytical development, manufacturing sciences, and Quality/Regulatory.
- Experience with current U.S. FDA, EUMDR, MDD, ISO 13485, ISO9001, MDSAP, and/or CMDR regulations, standards, and guidance documents (Preferred).
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