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.
Astor Bannerman's 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 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 (Electrical engineering 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 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?
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.
Growing business where you can really make an impact on your career whilst improving other peoples' wellbeing.
We cannot provide sponsorship - please apply only if you are already based in the UK and have the right to work without sponsorship - thank you.
We do not require support from Recruitment Agencies at this stage so no contact please.
Job Types: Full-time, Permanent
Pay: From £45,000.00 per year
Benefits:
Additional leave
Casual dress
Company events
Company pension
Cycle to work scheme
Free parking
Ability to commute/relocate:
Andoversford GL54: reliably commute or plan to relocate before starting work (required)
Application question(s):
What qualifications/ experience do you have that meets the role requirements?
Work authorisation:
United Kingdom (required)
Work Location: In person