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Post Market Surveillance Specialist

hace 3 meses

Bogotá, Bogotá D.E., Colombia Zimmer Biomet A tiempo completo

Requisition Number:
AMER27850

Employment Type:
Full-time

Location:
Bogota

Job Summary:

The Post Market Surveillance Specialist is document owner for Post Market Surveillance Activities; will document PMS Plans and, if the case, PMS Reviews (PSURs or PMSRs) records according to the applicable regulations (including MDR (EU) 2017/745); he /she will be responsible for working with Regulatory Affairs to ensure documentation has been reviewed and aligned with Notified Body (when applicable).

The PMS specialist will ensure Post Market Clinical Follow-up (PMCF) commitments are clearly documented within relative PMSPs, informed within clinical research department, and aligned with Notified Bodies.

Scheduling and coordination of PMS teams for review of proactive and vigilance activities according to schedule; gathering inputs from cross functional stakeholders, and elevating at-risk findings to senior management.

Track execution of PMS plans according to requirements; report to his / her manager on track, delayed and at risk PMS commitments; project management of PMS action items to ensure deadlines met.

Completes routine audits of PMCF commitments against PMSPs to ensure quality and transparency of commitments is maintained.

Principal Duties and Responsibilities:

  • Managing writing, reviewing and maintenance of post market surveillance (PMS) assignments; including document ownership of initial PMS plans (PMSPs), revised plans, tracking of Post Market Clinical Follow-up (PMCF) commitments and scheduling of PMS reviews (Periodic Safety Update Reports (PSURs) and/or Post market Surveillance Reports (PMSRs) as outputs) according to the PMS schedule.
  • Identify pertinent internal and external sources of clinical data for the Zimmer Biomet products necessary to fulfill the regulatory requirements
  • In collaboration with other team members as applicable and as needed, performs sales data searches and analysis, literature and registry reviews as well as complaints trending, similar devices in DAEN and HHEs on the products in scope.
  • Organize and lead PMS review meetings
  • Be accountable for getting PSUR / PMSR documents created, reviewed and approved in time as per plans
  • Support the Manager or Team Leader for Audit activities including the participation in Audits as clinical PMS SME as needed
  • Delivers results, drives for continuous improvement. Holds him/herself accountable for the results expected. Acts with a sense of urgency.

Expected Areas of Competence:

  • Proficient in English
  • written and spoken
  • Excellent written and verbal communications skills
  • Knowledge of regulatory compliance for medical devices
  • Demonstrated project management skills
  • Strong ability to interpret and disseminate relevant product information for regulatory purposes
  • Understanding of statistical methods
  • Ability to critically analyze and interpret scientific data
  • Have an analytic and strategic mindset
  • Ability to work within tight deadlines, adjust to changes in priorities
  • Ability to function independently
  • Ability to identify problems and research possible solutions
  • Possesses outstanding organizational skills, attention to detail and proofreading skills
  • Takes actions that are best for the company versus his or her individual unit
  • Encourages and supports information sharing and collaboration across teams and departments Demonstrates sound business ethics; shows consistency among principles, values and behaviors.

Education/Experience Requirements:

  • Minimum of a Bachelor's degree or equivalent education in health, life sciences, engineering or a similar discipline required.
  • Master and PhD degree preferred.
  • Medical Device Functional Experience (Clinical, Post Market Surveillance, Engineering, Regulatory, Quality or equivalent). Knowledge of Medical Device Directive and MDR (EU) 2017/745

Travel Requirements: 5%