Regulatory Affairs Manager - IVD - Dublin

Dublin South  ‐ Onsite
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Description

Regulatory Affairs Manager

In this role you will be responsible for ensuring the company's continuous compliance with the following regulatory standards:

* The FDA Quality System Regulation 21 CFR 820 (QSR).
* The In Vitro Diagnostic Medical Devices Directive 98/79/EC.
* The Medical Devices Directive 93/42/EEC
* Health Canada Medical Devices Regulations.
* ISO 13485 Quality Management Systems Requirements for Medical Devices.
* ISO 9001 Quality Management Systems Requirements
* Provide regulatory advice & support to the company business units.
* Liaise with all Professional & Regulatory bodies in the industry as appropriate on regulatory or legislative changes which impact on the company and to ensure effective implementation within the company.
* Manage and co-ordinate all company vigilance/recall activities.
* Provide guidance on worldwide regulatory requirements, providing regulatory strategies and co-coordinating during transfers, registrations.
* Work as part of project teams in support of product registrations and liaison with customers and regulatory bodies during this process.
* Create and maintain Product technical Files according to the IVD Directive 98/79/EC.
* Act as Regulatory Affairs representative on the Design Control/Change Committee.
* Responsible for maintaining awareness of the changing regulatory requirements.
* Represent Regulatory Affairs at regulatory and customer audits.

Skills and Behaviours Required:

* Preferably 3 years' experience in a regulatory affairs role in the Medical Device/IVD Industry.
* Understanding of current Regulatory Standards.
* Third level qualification in a science or related discipline or equivalent in terms of relevant operational experience.
* Excellent organisational, planning and judgement skills with excellent attention to detail.
* Excellent analytical/decision making skills
* Ability to identify and drive regulatory compliance improvements
* Ability to work independently

This is a great oppotunity to grow and develop in an extremely innovative start up IVD company. If you are intersted in the role and have the relevant skill set and experience please contact me Anna Mooney . Or apply below with an up to date CV.

To find out more about Real please visit www.realstaffing.com
Start date
12/2013
From
Real Staffing
Published at
21.09.2013
Project ID:
602548
Contract type
Permanent
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