Astor Bannerman

About the Company

With over 30 years’ experience, Astor Bannerman are leading UK manufacturers of Changing Places, specialist bathing, and care equipment. From initial site visit to installation and ongoing support, our expert team provides professional advice, bespoke design, and seamless project delivery. We also offer free CPD sessions for architects, occupational therapists, councils, and contractors, helping you specify compliant and inclusive facilities with confidence. Our commitment doesn’t end at installation — we provide full after-sales servicing and maintenance to ensure long-term reliability and peace of mind.

Listed Jobs

Company Name

Astor Bannerman

Job Title

Senior Compliance Engineer

Job Description

**Job Title:** Senior Compliance Engineer **Role Summary:** Lead the creation and maintenance of technical documentation, product classification, and testing plans for pediatric medical devices to ensure compliance with UK, EU, USA, and ROW regulations, while driving continuous improvement in R&D processes. **Expectations:** - 6+ years in medical device compliance or regulatory affairs, or an equivalent engineering degree. - Proactive, detail‑oriented, strong analytical and documentation skills. - Excellent communicator, capable of collaborating with cross‑functional teams and external regulators. **Key Responsibilities:** - Own and update Technical Content Files and product classification records. - Plan, conduct, and oversee internal and external product testing (IEC 60601‑1 series and other relevant parts). - Operate and maintain testing equipment. - Prepare and submit certification dossiers to regulatory bodies and test houses. - Collect, analyze, and report test data; provide recommendations for design improvements. - Execute risk assessments, FMEAs, and maintain ISO 9001, ISO 13485, ISO 14971 compliance. - Monitor changes in applicable standards and regulations; implement updates across product portfolio. - Drive process enhancements in testing, documentation, and compliance workflows. - Ensure all documentation (drawings, labels, manuals) is accurate, consistent, and compliant. **Required Skills:** - Technical engineering background (Electrical Engineering preferred). - Hands‑on experience in medical device testing and validation. - Deep knowledge of Class I medical device regulations (MDD, MDR) and international markets. - Proficiency with ISO 9001, ISO 13485, ISO 14971, IEC 60601‑1/2/6/11. - Strong analytical, risk assessment, and documentation abilities. - Self‑starter with organizational and project management skills. - Effective written and verbal communication. **Required Education & Certifications:** - Bachelor’s degree in Electrical Engineering, Biomedical Engineering, Medicine, or related scientific discipline (or equivalent experience). - Demonstrated experience in regulatory compliance for medical devices; certifications in regulatory affairs or quality management systems are a plus.

Eastington, United kingdom

On site

Senior

25-01-2026