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Post Market Surveillance Coordinator

Apply Now Job ID R-347084 Date posted 09/12/2019

Job Description Summary

Job Description

The Post Market Surveillance (PMS) Coordinator will support the PMS team in organizing and compiling assorted inputs needed for various national and international PMS reporting requirements. 

The incumbent will collaborate with cross-functional team members to ensure compliance to the applicable regulations, standards and company policies/procedures to help improve the lives of the people we serve by ensuring high standards of quality and safety of the products being produced and distributed.

This position plays an integral role in maintaining compliance with global regulations.

  • Assist the PMS team with the organization and compilation of assorted inputs needed to meet the requirements in generating PMS, Post Market Clinical Follow-up (PMCF), Clinical Evaluation Report (CER), Periodic Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP) and related reports.
  • Audit files for completeness.
  • Process approvals for related files and reports.
  • Provide reports to applicable internal and external customers.
  • Support internal and external audits.
  • Complete training by established due dates.
  • Identify and escalate quality and personnel issues as necessary.
  • Performs other related duties and responsibilities as assigned.

Skills and Experience

  • Prior experience coordinating departmental activities, programs and practices.
  • Basic knowledge of regulations and industry standards consistent with requirements for a manufacturer of globally distributed medical devices and pharmaceutical products.
  • Good written and verbal communication skills.
  • Strong computer skills.
  • Strong organization skills.
  • Team player with ability to successfully interact with representatives from a variety of disciplines within BDI Surgery and Becton Dickinson.

Minimum Requirements

  • Bachelor’s Degree required.
  • Minimum of 3 years of administrative support experience, preferably supporting a Quality Assurance department in the Medical Device and/or other regulated industry (Pharma, IVD).

Primary Work Location

USA RI - Warwick

Additional Locations

Work Shift

NA (United States of America)
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Manager, Post Market Surveillance Warwick, Rhode Island 13305608

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com