At a Glance
- Tasks: Ensure compliance and regulatory best practices for innovative medical devices.
- Company: Dynamic medical devices company in Cambridgeshire with a focus on innovation.
- Benefits: Strong salary package, performance bonus, pension, free lunches, and more.
- Other info: Opportunity for growth in a fast-paced, collaborative environment.
- Why this job: Join a team shaping lifesaving technology and enjoy diverse challenges.
- Qualifications: Experience in quality assurance, regulatory standards, and a relevant engineering background.
The predicted salary is between 63000 - 77000 £ per year.
Regulatory Affairs Specialist - Med Tech
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, which includes a performance bonus, pension, free lunches, and a variety of other benefits too.
Please note that they are ideally looking for someone to be based fulltime in the office.
If you would like to find out more about the company and this role then go ahead and make a confidential application and a member of our team will be in touch with more details
Regulatory Affairs Specialist - MedTech + More in Cambridge employer: Newton Colmore
Join a dynamic and innovative medical devices company in Cambridge, where your contributions will directly impact the development of life-changing technologies. With a strong focus on employee growth, this organisation offers excellent career progression opportunities, a competitive salary, and a comprehensive benefits package, all within a collaborative work culture that values your input in both regulatory affairs and quality assurance. Be part of a team that not only meets industry standards but also strives to improve lives globally.
