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What we do

Cambridge Consultants provides stimulating surroundings where cutting edge technologies and innovations challenge traditional approaches. To meet this, our approach to quality encourages applying technical expertise to provide a platform which encourages and facilitates creativity and innovation to meet global regulatory requirements.

The QA Group is responsible for maintaining the company management systems that support our business processes and comply with regulatory requirements to satisfy our clients’ expectations.

The role

We are looking for a Senior Quality Assurance and Regulatory Affairs Specialist to join our team.

The focus of the role is to provide company-wide regulatory support to our project teams, spanning both medical and non-medical disciplines, as well as supporting the QA Manager and Head of RA with operational activities of the Quality Management System and related management systems. This is a great opportunity to expand your knowledge, gain experience in a variety of different divisions and deepen your knowledge across multiple industries.

Ideally you will already have strong experience in the regulatory field, and this role will offer you the chance to utilise this to provide a strategic advantage to client projects while expanding our knowledge and experience of European, US and Asian regulations (for both medical and non-medical applications). You will also lead communication regarding key changes in the regulatory fields and interpret what they mean for both the team and the wider business.

This role strongly encourages demonstration and development of your leadership and project management skills to facilitate the work done by client project teams. This role involves running internal initiatives and allows you to own meaningful contributions to CC’s global systems as a quality and regulatory technical lead.

We would like you to be able to find pragmatic but robust solutions to new and existing problems under tough commercial, technical, time and regulatory constraints. You must understand and demonstrate the need to balance freedom to innovate on the one hand, with rigour in the design process on the other by applying your knowledge and experience of quality management appropriately to the individual project situation. This position will enable you to use your resourcefulness to contribute to projects with a widely varying breadth of disciplines, scale, complexity and requirements.

What you can bring

You will need to be a clear thinker, who can work independently, flexibly and inventively to facilitate others and show leadership in managing and undertaking activities. You must be a proactive communicator and have the ability to take ownership of initiatives, deliver results, and strive for continual improvement.

We are looking for someone with the ability to demonstrate a track record of developing and executing global regulatory strategies that align with business needs and deliverables. Previous experience with medical devices is strongly preferred but not essential. You are also likely to have a degree in engineering or the life sciences. In any case a key ability will be the skill and experience to interpret regulatory and standard requirements to ensure the downstream implications for our processes are clear.

Generous and flexible relocation support is available.

 

Learn about Life at CCWhat to expect when applying

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Benefits

  • Competitive salary, based on merit and reviewed annually
  • Company profit share scheme in addition to basic salary
  • Pension scheme
  • Life, disability and travel insurance, plus private healthcare
  • Free canteen - breakfast, lunch and refreshments
  • 25 days annual holiday plus public holidays, with flexibility to carry over / borrow
  • Relocation assistance if applicable
  • Excellent career development and training opportunities
  • Flexible working hours
  • Social committee
  • Discounted train season tickets, through Travel Plan Plus
  • Free shuttle service to/from Cambridge North train station, through Cambridge Science Park

Future prospects

Cambridge Consultants is committed to developing its employees' careers and has a flexible policy for individual capabilities and preferences. Promotion is linked to merit.

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