Senior Quality Assurance Manager – IVD – Cambridge
A fantastic opportunity has arisen for a Senior Quality Assurance and Regulatory Manager/ Director to join an innovative new start-up company based in Cambridge. As an organisation they are developing pioneering molecular diagnostic tools that will facilitate personalised medicine treatments for a range of significant diseases. This is an ideal position for an experienced QA professional who is keen to take up a new challenge and reap the rewards of joining an exciting new venture.
As the Senior Quality Assurance and Regulatory Manager/ Director you will report directly into the VP of Research Operations. The primary focus of the role will be to lead and manage all aspects of the QA strategy and regulatory compliance function. This will cover both key molecular products and services.
*Direct all aspects of the Quality Assurance and Regulatory Affairs functions, including Europe, US and Asia for key products as medical devices and associated clinical lab activities
*Responsible for the generation of regulatory submission documents and preparation of technical file documentation
*Serve as the company points person to interact with the appointed Notified Body
*Serve as the company representative during quality and regulatory audits
*Develop and maintain internal awareness and knowledge of regulatory standards, ensure compliance of the internal quality system, and provide suitable interpretation to the company
*Manage customer tracking as related to quality of products, complaints and post-market surveillance
*Develop and implement programs for audits (internal, vendors) as well as the CAPA system
*Promote a culture of compliance to regulations, standards and procedures and risk management throughout the organization
*Maintain an awareness of new and proposed legislation that impacts the business and communicate/implement as required.
To be considered for this position you must have a minimum of 5-7 years’ experience in QA ISO quality systems for IVDD (in-vitro diagnostics) and managing a quality system. Strong experience of ISO-13485, CE marking and 510 (K) submission is essential. As this is a key strategic role candidates must be at manager or director level. The ideal candidate will have exposure to molecular diagnostics and will be educated to a minimum of degree level in a scientific subject.
To find out more about this superb opportunity please contact myself, Lauren Gripton, of Paramount Recruitment on email@example.com
Keywords: quality, QA, regulatory, reg affairs, quality assurance, QA manager, QA director, IVD, in-vitro diagnostics, in vitro diagnostics, molecular, diagnostics.
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
Job Reference: Lg435453_1520001150
Broadcast As: 196
Salary Currency: GBP
Salary per: Annum
Job Type: Full Time
Job Term: Permanent
Job Industry: Biotech
Recruitment Consultant: Lauren Gripton