At a Glance
- Tasks: Ensure our medical devices meet compliance standards and improve lives.
- Company: Astor Bannerman, a leader in specialist medical equipment for over 30 years.
- Benefits: Join a growing team with opportunities for professional development and impact.
- Other info: Dynamic work environment with a focus on innovation and compliance.
- Why this job: Be part of a mission-driven company making a real difference in healthcare.
- Qualifications: Experience in medical device testing and a relevant degree or extensive experience.
The predicted salary is between 40000 - 50000 £ per year.
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.
Compliance Engineer employer: Astor Bannerman
Astor Bannerman is an exceptional employer that prioritises the well-being of its employees while making a significant impact on the lives of individuals with complex needs. With over 30 years of experience in the medical equipment sector, we foster a collaborative and innovative work culture that encourages professional growth and development. Our commitment to investing in our future means that as a Compliance Engineer, you will play a vital role in shaping the evolution of our products, all while enjoying a supportive environment that values your contributions.
