Post Market Surveillance Specialist
4 weeks ago
Vantive: Revolutionizing Kidney Care
Baxter is embarking on a journey to separate its ~$5B Kidney Care segment into a standalone company, Vantive. This new entity 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.
As a Post Market Surveillance Trainee at Vantive, you will become part of a community of professionals driven to improve patients' lives. Your role will involve collecting, analyzing, and interpreting data related to medical device use in real-world clinical settings.
Key Responsibilities:
- Evaluate potential product quality complaints and initiate timely actions to ensure compliance with regulatory requirements.
- Own and process quality complaints, ensuring applicable records and actions are maintained within the proper Quality System.
- Determine, facilitate, and/or approve reportability assessments and decisions based on applicable procedures.
- Author and submit 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 (PMSP, PSUR, etc.) 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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