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Senior Compliance Engineer

Posted 24 Mar 2024
Work experience
2 to 4 years
Full-time / part-time
Full-time
Job function
Degree level
Required language
English (Fluent)

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Why join us?

CMR is an exciting and evolving company to be joining right now. Our commitment to our goal of building a world-class medical devices company is underpinned by the ground-breaking innovation of our next generation of surgical robots and a diverse team of talented and supportive individuals. Everyone at CMR has the passion and desire to make a real difference to the way minimal access surgery is developed and delivered.

We’re breaking new ground which makes working here exciting, it provides autonomy, opportunity and makes the things you do visible – if you’re great at managing your own time, are creative, patient and resilient, we think you’ll fit right in.

The Role

We’re looking for an exceptional Compliance Engineer to join our Systems and Technology Team, based in Cambridge. You will bring expert knowledge and rigour to our world leading technology development and product. With your passion for detail and excellence, you will help us bring the next generation of minimal access, surgical-assist robot to global markets.

Working within the Technology function, you will efficiently navigate and appreciate the technical details of the relevant standards to ensure our surgical robot meets technical compliance specifications.Liaising with both design engineers and regulatory teams, you will ensure compliance and safety measures are understood and implemented within the design and reflected accurately in risk management as required. Your collaborative nature and practical approach will enable you to positively manage a range of stakeholders across the business, to ensure all aspects of compliance are delivered to the highest standard and suitable for global markets.

Responsibilities

  • Pragmatically driving all aspects of compliance across a multi-disciplinary team responsible for medical device development throughout the full development lifecycle
  • Working with the Regulatory team to understand which standards are applicable across global markets of interest
  • Proactively tracking standards to inform design teams of potential design or risk changes and ensuring that internal specifications and requirement documents reflect any updates
  • Compiling and maintaining a comprehensive mapping between clauses in standards and their applicability to the design
  • Highlighting and assisting coordination of compliance related activities for risk, verification or validation as a result of standard changes
  • Liaising with external test houses to ensure successful testing of the product to required standards

About you

We’re a high growth company and roles can change and evolve. You’ll need to be willing to turn your hand to anything within the Systems and Technology team remit that supports the team with delivering its objectives.

To be successful in this role, you’ll need to have/be:

  • A degree level qualification
  • Demonstrable detailed knowledge of the product approval process
  • Practical experience of ensuring compliance with EN 60601
  • Technical understanding of complex electro-mechanical devices, ideally in a medical environment
  • Knowledge of ISO standards, FDA, MDD, MDR and regulations applicable to the design and development of medical devices
  • A genuine desire to help and support team members so that we can all achieve our best

It would also be helpful if you have:

  • Excellent planning and organisational skills
  • High attention to detail
  • Exceptional communication skills

The Package

We offer a competitive salary and a great benefits package including non-contributory pension, private healthcare and a bonus scheme. In addition, you’ll be joining a company with a fabulous culture of ambition, creativity and teamwork. CMR is committed to promoting a diverse, open and collaborative work environment – a place where we can be ourselves and succeed on merit. We believe an environment like this is where ideas can truly flourish and balanced with a healthy dose of fun, it ensures that our people stay and develop. We welcome applications to join our team from all qualified candidates, regardless of their characteristics.

Cambridge Medical Robotics is a surgical robotics company.

Healthcare
Cambridge
150 employees