Company: Thornshaw Recruitment
Closing Date: 02 Jan 17
Salary (£): On Application
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 firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
Barton House 6 Old Dublin Road Stillorgan Co. Dublin
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