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 (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 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
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.
Pay: £45,000.00-£50,000.00 per year
Benefits:
- Casual dress
- Company events
- Cycle to work scheme
- Enhanced maternity leave
- Enhanced paternity leave
- Free parking
- On-site parking
- Referral programme
- Work from home
Ability to commute/relocate:
- Cheltenham GL54 4LB: reliably commute or plan to relocate before starting work (preferred)
Application question(s):
Education:
Experience:
- Compliance : 4 years (required)
Work authorisation:
- United Kingdom (required)
Work Location: In person
