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Post Market Surveillance Specialist (MDR) at USA - Smith & Nephew, Inc.

Posted in Engineering 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Cordova, Tennessee





Job Description:

Job Description

Summary

The PMS Specialist (P3) assures compliance with national and international regulations with reference to PMS at assigned Smith & Nephew sites. He/she assures consistent, thorough PMS output as required by established procedures.

Essential Functions

Produce periodic PMS Reports by product family and support the generation and update of PMS plans. 65%
Perform periodic trend analysis as a PMS early warning system on complaint data. 5%
Lead or support of PMS related projects to improve source data required for PMS activities. 5%
Support other departments with customized statements and other output as required (ad hoc requests). 5%
Support responding to requests from competent authorities, registries, and notified body. 4%
Maintenance of links of the PMS group with other PMS-related groups (complaint management, product investigations, clinical research, regulatory, development, etc.). 2%
Detect, select and forward relevant external information (competitor FSCA, authority warnings, etc.). 2%
Maintenance of local PMS procedure and forms. Support global PMS procedures and forms. Manage training conduction and documentation for local team members for all local training activities (“on-the-job” training and procedures). 2%

Requirements

Education
3-5-year Bachelor's level degree in science, medical or engineering/equivalent experience required

Licenses/Certifications
N/A

Experience

1-3 years experience in the field of PMS within the medical device industry is preferred.

Competencies
- MS Excel
- MS Word
- MS Outlook
- Pilgrim
- SAP
- PLM

Supervision
N/A

Other
- Statistical knowledge: identification of significance of trends and issues.
- English, written and spoken
- national language, written and spoken (OUS)
- technical (report) writing
- communicational skills
- presentation
- time management
- problem solving
- team player
- influence
- work well under pressure
- ability to work independently / can make day-to-day decisions independently, cannot change policies or procedures without approval
- analytical ability
- desire to learn





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