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Job Details

Regulatory Affairs Specialist

Company: Thornshaw Recruitment
Location: South Dublin
Reference: DB9565
Closing Date: 21 Oct 17
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

On behalf of my client I am recruiting for a Regulatory Affairs Specialist.

Requirements:

 This is a permanent role and a great opportunity for career development within the medical device/diagnostics industry. 
You will report to the Regulatory Affairs Supervisor and you will work closely with the Quality, Regulatory and Sales & Marketing teams. 
Responsibilities:
• To ensure the company’s continuous compliance with the following regulatory standards: 
o The FDA Quality System Regulation 21 CFR 820 (QSR)
o The In Vitro Diagnostic Medical Devices Directive 98/79/EC
o The Medical Devices Directive 93/42/EEC
o Health Canada Medical Devices Regulations
o ISO 13485 Quality Management Systems Requirements for Medical Devices
• Manage and co-ordinate all company vigilance/recalls activities 
• Provide guidance on worldwide regulatory requirements, providing regulatory strategies and co-ordinating during transfers, registrations
• Work as part of project teams in support of product registrations and liaison with customers and regulatory bodies during this process
• Act as Regulatory Affairs representative on the Design Control/Change Committee 
• Experience in UDI/GMDN environment is required 
Applications are invited for candidates with the following background and experience:
• 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 judgemental skills with excellent attention to detail
• Excellent analytical/decision making skills
• Ability to identify and drive regulatory compliance improvements 
• Ability to work independently 
• Have the ability to have a positive influence in a team base environment
• Excellent written and verbal and presentation skills
• Good working knowledge of Microsoft Excel, Word and PowerPoint


For a full Job Spec and to apply for this role please call Deirdre on +353 1 2784671 or e-mail dbolger@thornshaw.com


Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
 

Apply for this job: Regulatory Affairs Specialist

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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