Amazing client is looking to hire for a 12+ month contract role that could get extended or convert to direct hire. The Post-Market Surveillance Specialist ) assures compliance with national and international regulations with reference to PMS at assigne company sites. Candidate will ensure consistent, thorough PMS output as required by established procedures.
Can be 100% REMOTE ( or in person for candidates living close to Andover, MA or Memphis, TN)
location: Andover, Massachusetts
job type: Contract
salary: $45 - 65 per hour
work hours: 8am to 4pm
- Produce periodic PMS Reports by product family and support the generation and update of PMS plans.
- Perform periodic trend analysis as a PMS early warning system on complaint data.
- Lead or support of PMS related projects to improve source data required for PMS activities
- Support other departments with customized statements and other output as required (ad hoc requests).
- Support responding to requests from competent authorities, registries, and notified body.
- Maintenance of links of the PMS group with other PMS-related groups (complaint management, product investigations, clinical research, regulatory, development, etc.)
-Detect, select and forward relevant external information (competitor FSCA, authority warnings, etc.)
- 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).
Travel: not likely but maybe up to 10%
Education: 3-5-year & Bachelor's Degree in science, medical or engineering/equivalent experience required
1-3 years' experience in the field of PMS within the medical device industry is preferred.
- MS Excel, - MS Word, - MS Outlook, - Pilgrim, - SAP, - PLM
- Statistical knowledge: identification of significance of trends and issues.
- English, written and spoken
- technical (report) writing
- communicational skills
- presentation skills
- time management
- problem solving
- team player
- 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
- Experience level: Experienced
- Minimum 3 years of experience
- Education: Bachelors (required)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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