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IFU Coordinator

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Job Description

The AKKA Technologies Group (12'000 employees, 1.2b EUR turnover) is a leading technical consultancy group, developing its AKKA LifeSciences brand through Europe.

On behalf of one of our best clients, a leading medical device manufacturer we are currently seeking an IFU Coordinator to join their international team on a permanent basis as soon as possible.

The role:

Coordinating, controlling, and supporting any activities relating to Instructions for Use (IFUs), including implementation of changes, release of IFUs and supporting process changes and technical implementation of IFUs (eg warehouse control, translation and printing process).
Support design and participate in the development of new IFUs in compliance with applicable regulations also of internal and external audits and inspections (Competent Authority, Notified Body).
Create, maintain and control local processes for creating, maintaining, and changing IFUs and leading of projects and subprojects pertaining IFUs.
Support of submissions to international authorities with regards to international regulations for IFUs (eg for product renewal) and Identify potential roadblocks, provide proposed solution and escalate to supervisor.
Leading and supporting of CAPAs pertaining IFUs and tracking of external standards and regulations applicable for IFUs.

The profile:

BSc or MSc degree (or equivalent education in technical area - biomedical sciences or engineering)
3 - 5 years Labeling/Regulatory Affairs/QA experience in medical device industry would be advantageous.
Ability to independently handle complex tasks in complex matrices of responsibilities, into time-dependent sequencing with realistic but aggressive timelines.
Resolve problems by identifying and applying solutions from acquired experience and the ability to defend the own position and convince other people about regulatory requirements and priorities.
Excellent command of English and German both verbal and written
Sound and comprehensive communication and diplomacy skills are required in order to achieve internal and external customer satisfaction.
Skilled in the use of the common MS Office applications (Microsoft Office Suite).

If this sound like your next challenge please send me your updated CV to (see below) or call me for more details.

This is a Permanent position.
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