Executive, Post Marketing Surveillance (Vantive)

Roles and Responsibilities

Job Summary:

Post-market surveillance involves collecting, analyzing, and interpreting data related to medical device use in real-world clinical settings. The Post Market Surveillance Trainee will be responsible for evaluating potential product quality complaints, initiating timely actions in association with coordinating the investigation to complaint closure. Ensure applicable, local, national and international regulatory requirements and internal expectations are met.

Essential Duties and Responsibilities:

• Evaluate potential product quality complaints and initiate applicable records and actions within proper Quality System.

• Own and process quality complaint as per applicable procedures.·

• Determine, facilitate and/or approves reportability assessments and decisions based on applicable procedures.·

• Author and submit applicable regulatory reports (MDR, MIR, etc.) to competent authorities when deemed required.·

• Monitor the status and progression of complaints under investigation and initiate actions to facilitate its resolution and closure.·

• Review and approve the results of Engineering, Manufacturing, Quality, Service and/or Supplier evaluations and investigations of complaints.

• Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints to drive continuous improvements within the department and organization.·

• Performs other duties as needed and assigned.

Qualifications:

• Demonstrate a high level of motivation and proactive personality.

• Excellent verbal and written communication skills.

• Display attention to detail to ensure accuracy in complaint documentation and regulatory reporting.

• Maintain a customer- and patient-focused attitude to handle complaints with empathy and professionalism.

• Analytical approach to problem solving.

• Exhibit ability to handle workload independently and work collaboratively within a team.

• Well organized and able to multitask effectively in a rapid paced environment, as well as show assertiveness, when interfacing with other personnel during the complaint handling process.

• Demonstrate the ability to meet deadlines consistently.

Education and/or Experience:

Bachelor’s Degree or equivalent – Preferred: engineering, nursing, biomedical, life science, or equivalent (S.T.E.M.).