Senior Quality & Regulatory Affairs Manager

Posted 12 October by aspire cambridge ltd

aspire cambridge ltd are currently recruiting for a Quality & Regulatory manager to join a Software company that are creating a game-changing software to aid medical devices based in Barrington, Cambridgeshire.

A fantastic opportunity has arisen for a Senior Quality & Regulatory Affairs Manager, who will be responsible for managing and evolving our regulatory and compliance systems to ensure that we can continue to expand worldwide in this challenging field. You will be responsible for maintaining and evolving the Quality Management and Information Security Management systems, arranging internal and external audits, and liaising with regulatory bodies.

Main duties:

  • Responsibility for ensuring that we have the necessary, up-to-date regulatory clearances and approvals in the various jurisdictions in which we operate
  • Developing and implementing systems to ensure ongoing compliance, including the Quality Management System and Information Security Management System, and run these systems day-to-day
  • Ensuring that these systems are being used correctly and effectively across the company
  • Arranging and managing internal and external audits, including follow-up on any actions identified
  • Researching the regulatory requirements in new territories, and extending our systems to ensure compliance
  • Keeping up to date with developments in applicable regulation, and improving our systems to take these into account

Skills and experience:

  • A degree in a numerate discipline
  • Experience in quality control systems in a highly regulated environment
  • Familiarity with relevant standards, in particular ISO 13485 and ISO 27001
  • Excellent people skills, with a track record of dealing with government and regulatory bodies

Start: ASAP

Duration: Permanent

Hours: Full Time

Location: Barrington, Cambridgeshire

Salary: £50,000 - £55,000

If you are interested in this position, feel you have the relevant skills and would like to apply please call our team on or apply online. Whilst we’d love to get back to every applicant, it is not always possible, so if you haven't heard from us within 3-5 days, please note that your application has not been successful on this occasion.

aspire cambridge ltd is acting as an employment agency ins regards to this vacancy. Our accredited recruitment consultants offer specialist marketplace expertise across our seven specialist recruitment divisions; engineering and manufacturing, finance and accountancy, hospitality, information technology, legal and hr, office support and sales and marketing. Our ever expanding network of client companies exceeds 3000 active organisations that we engage with on a regular basis. We have an unrivalled knowledge of the jobs marketplace so it’s no wonder that we hold an impressive track record of exceeding client and candidate expectations. How do we do it? By “placing people first”.

Reference: 33539565

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