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Regulatory and Quality Manager - IVD in West Midlands
Our client is a leading global diagnostics company that develop a range of ELISA based immunoassays for use on their patented microplate analysers. Due to strong global demand they are seeking a qualified professional to join their UK team as Regulatory and Quality Manager.
In this role you will have direct responsibility for technical files (STED), international registrations, and to keep the company abreast of new regulations that are applicable. You will also assist with FDA 510(k) premarket submissions and clinical trials and act as the Responsible Person.
Your Quality Assurance responsibilities will include risk management, auditing and new product development design control as well as dealing with other QA queries as required. You will also act as the QA representative for the company across its UK and European sites.
Degree or higher in a scientific or engineering subject.
A minimum of 5 years experience working with IVD devices in the diagnostics sector in a regulatory or quality role.
Specific knowledge of International standards and regulations inclusive of ISO 14971 and 13485, FDA, and EC/98/79 IVDD.
The ideal candidate must be able to work independently and also manage project teams, whilst staying up to date with the current regulatory changes.
Exceptional communication skills are essential and you should be able to communicate effectively through both written media and verbally.
Strong mediation and negotiation skills.
Formal qualifications in auditing and/or project management would be an advantage.
Full driving licence.