Regulatory Affairs Vigilance Specialist

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I currently have an immediate opening for a Regulatory Affairs Vigilance Specialist for a leading medical device manufacturer located in Athlone.With a company who develops and manufactures a wide range of products and therapies with emphasis on providing a complete continuum of care to diagnose, prevent and monitor chronic conditions.

This is a permanent position with a competitive salary and comes with fantastic benefits.

What you will be doing as Regulatory Affairs Vigilance Specialist:

As a Regulatory Affairs Vigilance Specialist, you will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department

* You will be responsible for ensuring that the company meets its statutory Regulatory obligations under the Medical Device Vigilance requirements of the Medical Device Directive (MDD) within the EEA, and comparable reporting responsibilities in other countries within the EMEA

* You will be responsible for the timely submission of EU Vigilance Reports to external regulatory agencies in order to maintain regulatory compliance.

* Ability to liaise and communicate effectively with the business , Regulatory Affairs personnel and other functions as appropriate for resolution of queries related to vigilance reporting, User Reports or requests from Competent Authorise.

* Cultivate an expertise in the company's complaint handling system and vigilance related systems in order to perform vigilance tasks effectively.

* You will also support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports. You will also support both internal and external audit activities.

What I need to be a Regulatory Affairs Vigilance Specialist:

* Leaving Certificate or equivalent level. A third-level or vocational qualification in a relevant area would be an advantage.

* Applicants should ideally have experience of working within a highly regulated environment (preferably healthcare) and have experience in communicating with government or statutory authorities and should have the ability to generate and review reports on regulatory matters in a timely manner, as well as be accountable for the accuracy and integrity of information provided as input for decision-making.

* Experience/understanding of complaint handling or CAPA processes are desirable.

* Ability to analyse and interpret data, as required, in order to provide continuous improvement and resolution of issues.

* Ability to meet strict deadlines and targets to maintain regulatory compliance.

* Candidates must be a good communicator and are fluent in English, both in writing and speaking. Candidates should also possess good IT and Keyboard Skills and the ability to work with MS Word, MS Access and MS Excel, along with Corporate Complaint-tracking and Documentation Systems

* Discretion and sensitivity when processing confidential information on patient-outcomes or institutions.

If you meet the above requirements and are interested in hearing more don't hesitate in applying. Don't miss out on this opportunity in Athlone to become part of a leading company. Please respond with an updated CV

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales