Regulatory Affairs Specialist - MedTech + More in Cambridge)

Regulatory Affairs Specialist - MedTech

A growing medical devices company in Cambridgeshire are currently in need of an experienced quality assurance and regulatory affairs specialist.

This is an excellent opportunity for a QARA specialist to join this team of experts and work on highly complex medical technology, across multiple territories and product ranges.

This is a key role in the development of lifesaving and life-improving medical devices, ensuring compliance, assurance, and regulatory best practice across the entire design and manufacturing process on products and services that will be launched in Europe, North America, and the APAC region.

This company have a proven track record of delivering step-changes in technology through innovation and intricate design, and you will fit right in if you have a sharp eye for detail and enjoy working in an environment that prioritises autonomy and responsibility.

To be successful in this role you will need to have knowledge of quality assurance and regulatory standards within the UK and Europe. So, in-depth knowledge of ISO 13485, CE Marking, and other standards will be essential. This role will give you the chance to shape their strategy and processes while providing great opportunities for growth and development.

Undertaking internal audits will be important in this role so hopefully you have experience of this in your current role.

To complement your experience, we are looking for candidates that have an engineering or biomedical engineering background, ideally to a minimum of a bachelor's degree. The client is open-minded on this so we are also considering candidates from a scientific background. The ideal experience level will be from 2-to-5 years, but this is open for the right candidate.

You will be rewarded with a challenging role that you will never get bored with. As new medical devices are being developed all the time you will always be working on something new rather than managing pre-existing regulatory affairs documentation.

The company are offering a strong package on this role, depending on your overall experience.

• performance bonus
• pension
• free lunches
• a variety of other benefits too

Please note that they are ideally looking for someone to be based fulltime in the office.

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