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Job Details

Head of Quality & Regulatory Affairs

Company: Thornshaw Recruitment
Location: Dublin
Reference: DB9282
Closing Date: 21 Apr 17
Type: Permanent
Salary (£): On Application

Job Summary:

On behalf of our client, a Dublin based medical device company, I am recruiting for a Head of Quality & Regulatory Affairs.


This is an exciting and challenging opportunity. As a member of the senior management team you will be responsible for the following: 

•    Management of the current Quality System.  
•    Manage Development QA Systems
•    Continuous improvement of the system to meet the evolving expectations of customers, business partners and regulators. 
•    Preparation for and completion of premarket approval applications (PMA) to the FDA for new products
•    Be a key player in the transfer of new products from Development to Manufacturing. 

Candidates with the following background and experience are invited to apply: 

•    Science Degree or equivalent
•    Qualification in Quality Assurance is essential.
•    More than 8 years’ experience in a quality assurance role in the pharmaceutical, healthcare or medical device/IVD sector and in a FDA regulated environment is essential with no less than 3 years’ experience working in a Senior Management role (director Level)
•    Successful preparation for and completion of premarket approval applications (PMA) to the FDA.
•    Successful preparation for and completion of an FDA Audit
•    Intensive knowledge of quality management systems and current International and European regulations/standards with respect to medical devices.
•    Successful implementation of a Quality IT System implementation is essential

For more information and a full Job Spec please call Deirdre at +353 1 2784671 or e-mail

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

Apply for this job: Head of Quality & Regulatory Affairs

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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