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Job Details

Senior Regulatory Affairs Specialist

Company: Thornshaw Recruitment
Location:
Reference: TD9535
Closing Date: 15 Sep 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

In partnership with our client, a leading medical device company we are working with them on a new vacancy for a Senior RA Specialist. The role is a permanent position reporting directly into the RA Manager

Requirements:

In partnership with our client, a leading medical device company we are working with them on a new vacancy for a Senior RA Specialist.   The role is a permanent position reporting directly into the RA Manager 

As a Senior Regulatory Affairs Specialist, you will be a key member of their Regulatory Affairs group and required to demonstrate flexibility as priorities change. 

Key role of this position is to support department goals and continuous improvement initiatives, prepare and support vigilance on regulatory data related to the company’s range of medical devices. 
Maintains site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDD, CMDCAS, IEC 60601, and other International Regulations.

As part of your role you will be a key member of the New Product Introduction, design control teams and site engineering projects to ensure device compliance to appropriate International Regulatory requirements.

QUALIFICATIONS

Third level qualification in an engineering or science discipline.

EXPERIENCE REQUIRED

At least 5-7 year’s experience in an RA role within an FDA and / or ISO 13485 regulated medical device environment.
Demonstrable knowledge of 21CFR820, 803 and 807, and ISO 13485 requirements
Experience in internal auditing for compliance to Medical Device QSRs an advantage

For further details please contact Tina on +353 1 278671 or email your CV directly to tdunne@thornshaw.com

Apply for this job: Senior 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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