regualtory affairs coordinator regualtory affairs specialist regulatory regulatory affairs regualtory affairs jobs regulatory affairs opportunities registration refgulatory affairs office
Dublin City Centre Dublin North Leinster
2 - 3 Years
On behalf of our client, a medical device company, we are currently recruiting for a Regulatory Affairs Officer.
• Ensure compliance with Medical Device, In Vitro Diagnostics & Food Supplement directives
• Communicate with Notified bodies, local & international regulatory authorities regarding certification, vigilance & compliance.
• Subcontractor Management & Auditing
• CE marking of products
• Project Management
• Responsible for Quality Systems e.g. ISO13485 & 9001 compliance & audit programme.
• Coordinate & lead audit programme and carry out internal and external audits (Quality Systems & GMP)
• Direct the planning and implementation of the Quality Systems, and take ownership of local Quality System in line with Global Quality System.
• Degree in Science/ Pharmacy required. Postgraduate qualification is desirable.
• A Minimum of 3 years experience in a Global Regulatory Environment, preferably in Medical Device Sector.
• Lead Auditor competence level
• Ability to effectively influence affiliates, regulatory agencies and sub contractors.
• Solid experience in Quality Systems ISO13485 & 9001.
• Ability to lead and support several concurrent projects/products
• Self-motivated, flexible and open to changing requirements
• Be able to work autonomously and have good problem solving skills.
• Highly driven with enthusiasm to meet role requirements and to cope under demanding pressure
• Ability to prioritise decisions and activities to ensure efficient use of resources and address critical issues impacting the business
• An innovative frame of mind - open to applying creative techniques to find a solution
• Execution - persistent drive for results utilising sound project focus, organisational and problem solving skills.
• Ad hoc International travel is a requirement of the role- flexibility required
For a full Job Spec and further information please call Linda at 01 2784671 or e-mail your CV to email@example.com
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