Astor Bannerman designs, develops and manufactures specialist medical equipment that directly improves the lives of children and adults with complex needs. Our products are primarily focused on washing, bathing, changing and handling solutions and we have been established for over 30 years.
We are now heavily investing in our future as we expand and our Medical Device product line is continually evolving and growing. Therefore, 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 people’s lives, then this is a perfect opportunity.
Requirements
- You’ll 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 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 FMEA’s 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
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
- Free on-site parking.
- Benefits include Healthcare scheme, bike to work & the day off work on your birthday
- Growing business where you can really make an impact on your career whilst improving other peoples’ well-being.
Please note that you must be located in commutable distance to Cheltenham (GL54) or be willing to relocate.
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