Senior Quality Assurance Manager - IVD - Cambridge

Paramount Recruitment Ltd

Job ID :


Company Type :

Staffing Firms

Industry :

Science and Research

Education Level :

Bsc,Master of Science,phD

Address 1 :

United Kingdom,--Cambridge,Cambridge,

Key Skills :

In-vitro diagnostics

Salary :


Date Posted :

02 Mar, 2018

Company Name :

Paramount Recruitment Ltd

Location1 :


Job Category :

Scientific Jobs

Experience :


Job Type:


Travel Amount:



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.

Key responsibilities:
*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

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.

Company Name:

Paramount Recruitment Ltd


No. 5 Lower Temple Street,No. 5 Lower Temple Street


Staffing Firms


United Kingdom


B1 1QU



less than 100


Pharmaceutical Recruitment



Phone No. :

+44 (0)121 616 3460

Specialist in Permanent, Contract and Interim recruitment solutions to the Pharmaceutical and Life Science industries throughout Europe.

Our goal is to assist our candidates in finding that “perfect fit” between individual skills and experience and the right career opportunity. We identify and only present the positions that accurately reflect a chosen professional path. We discuss opportunities in detail, respect choices and ask permission prior to presenting any details to prospective clients. We brief and prepare every candidate for client meetings, and once the interview process is complete, provide feedback in a timely manner.

Our clients choose Paramount because:
• We are a Corporate Member of REC (Recently Inspected)
• We aspire to build long-term partnerships
• Our consultants are highly trained with expert market knowledge
• We are one of the most effective advertisers on the Internet
• We provide tailored Recruitment Solutions
• We keep up-to-date with Industry information – Salary scales, market knowledge, skills shortages

For more information,visit

View all Paramount Recruitment Ltd Jobs

Established in January 2003, Paramount Recruitment is an independent recruitment consultancy which has grown to be one of the leading recruiters to the Healthcare, Pharmaceutical and Scientific industries, throughout the UK and Europe.

Our Vision is to be internationally recognised and admired as the number one recruitment solutions provider to the Healthcare Pharmaceutical and Scientific industries.

Our Mission is to employ the best Consultants, whose aim is to deliver a professional and superior service to ensure our clients achieve their business goals and our candidates attain their career aspirations.
Our Values define who we are as an organisation and what makes us different. They influence the way we work with each other – and the way we serve our clients and candidates:

  • Respect - Paramount people listen, engage and contribute to ensure we make  the best possible decisions.  We are proud to work in recruitment.  Our diversity    makes our team uniquely adaptable to whatever challenges be it location, industry or culture we work in.
  • Integrity - Credibility means everything.  We are honest and transparent in our approach with everyone.
  • Entrepreneurial - We make it our business to excel when others can’t.  We relish the opportunity of a challenge using innovative and unique solutions.  We strive to be the agency of choice.
  • Experts Continuous knowledge building and sharing is central to our success.  We work in partnership with clients and candidates, our combined knowledge of industry and recruitment ensures we match the right person to the right job at the right time.
  • Success – At Paramount we recognise and reward achievement, we nurture an environment where people can fulfil and maximise their potential.

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