Vigilance Administrator
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Job Description
About the role
- The Vigilance Administrator provides essential administrative and operational support to the EMEA Vigilance Centre of Excellence, enabling timely, accurate, and compliant execution of vigilance activities in line with internal procedures and external regulatory requirements while fostering a culture of quality, innovation, and operational excellence.
Main responsibilities will include
- Monitor and manage dedicated vigilance shared mailboxes and triage incoming communications.
- Support Vigilance Specialists with the preparation and submission of vigilance documentation to Competent Authorities and Notified Bodies, where applicable.
- Maintain accurate and complete vigilance records in TrackWise and local tracking tools.
- Support the generation of vigilance metrics, dashboards, and management reporting.
- Assist with non-reportable Decision Tree processing and documentation.
- Ensure adherence to vigilance SOPs, quality standards, and data integrity requirements.
- Support internal and external audits, inspections, and regulatory readiness activities.
- Identify opportunities for administrative process improvement and operational efficiency.
- Undertake any other duties as requested by EMEA Post Market Quality leadership to support the EMEA and Global Quality organisation.
About you
- Strong attention to detail.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to lead multiple tasks and prioritize effectively with a pro-active attitude.
- Strong problem-solving skills, written and verbal communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Knowledge of TrackWise (desirable).
- Nice-to-have experience in Medical Device Quality Assurance (QA) and/or Regulatory Affairs (RA).
- Proficient English (essential)
Why Join Us?
Not included in the source posting: qualifications.
Skills
Who can apply
The employer didn't state any visa, work authorization, citizenship or clearance requirements in this posting. Confirm with the employer before applying.
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