At a Glance
- Tasks: Ensure compliance for innovative medical devices and oversee testing processes.
- Company: Join a dynamic team creating life-changing paediatric medical equipment.
- Benefits: Competitive salary, flexible hours, healthcare scheme, and pension contributions.
- Other info: Immediate start available in a fun, supportive environment.
- Why this job: Make a real impact on people's lives while advancing your career.
- Qualifications: Experience in medical device compliance and strong analytical skills required.
The predicted salary is between 40000 - 50000 £ per year.
Astor Bannermans Medical Device product line is continually evolving and growing. We require an experienced compliance engineer to help us navigate our regulatory requirements for new and existing products. If you want to be part of a company creating products that directly improve peoples lives, then this is a perfect opportunity.
Requirements
- Youll be a technically capable and detail orientated engineer with experience in medical device testing and certification, with a strong grasp of compliance standards.
- A relevant degree i.e. Engineering (Elec eng. preferred), Medicine or another relevant scientific discipline or 6 years experience in a compliance or regulatory affairs role.
- Hands on experience in product testing and validation.
- Knowledge of regulatory requirements for Class I medical devices to MDD and MDR.
- Experience and competence complying to ISO9001, ISO13485, ISO14971.
- Experience testing and complying to IEC60601-1 and other parts (such as -2, -6, -11).
- Strong analytical and documentation skills.
- Proactive, organised, self-starter & passionate about standards.
- Confident communicator, able to work across function and to external agencies.
Responsibilities:
- Technical Content File creation, maintenance and ownership.
- Support product classification levels of medical & machine products.
- Plan, conduct and oversee all testing both internally and externally.
- Operate and maintain any testing equipment.
- Ensure compliance for the full product range, regularly updating where needed to UK, EU, USA and ROW.
- Support Certification submissions and liaise with regulatory bodies and test houses.
- Collect and analyse test data, providing detailed reports and recommendations.
- Carry out risk assessments and FMEAs to support safe and compliant design.
- Stay up to date on applicable standard and regulations.
- Drive improvements across R&D in test methods, documentation and compliance processes.
- Ensure documentation, drawings, labels, manuals, etc. are accurate and consistent.
- Integrate best practice into the R&D engineering team.
Our Company
We design, develop and manufacture paediatric medical equipment. Our products are primarily focused on washing, bathing, changing and handling solutions that directly improve peoples lives. We have been established for over 30 years but are now heavily investing in our future as we are expanding.
Why should you apply?
- Competitive salary based on experience & flexible hours.
- Working in a small, fun & dynamic R&D and Quality team.
- Surrounded by the beautiful Cotswolds but close to Cheltenham (GL54).
- Immediate start possible, on-site parking.
- Healthcare scheme, bike to work & pension contribution.
- Growing business where you can really make an impact on your career whilst improving other peoples wellbeing.
Senior Compliance Engineer in Cheltenham employer: Astor Bannerman Medical Ltd
Astor Bannermans is an exceptional employer, offering a unique opportunity to work in a dynamic and supportive environment focused on creating innovative paediatric medical equipment that enhances the lives of children and their families. With a competitive salary, flexible working hours, and a strong emphasis on employee growth, you will be part of a small, passionate team in the picturesque Cotswolds, where your contributions will directly impact both your career and the wellbeing of others.
Contact Details:
Astor Bannerman Medical Ltd Recruitment Team
