Reference Number: JO-2305-516886
Risk Management Compliance Engineer
Job Type: Contract
Compliance Engineer (risk management)
£27 per hour
This position is in the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence located in Cambridge, UK.
• Lead risk management activities for combination product and medical device development programmes, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
• Support and facilitation of effective risk management activities internally, at external design companies.
• Generation, approval, and retention of risk management documentation ensuring that quality and regulatory requirements are satisfied.
• Ensure combination product risk management activities are compliant with quality and regulatory standards, both internal and external.
• Provide input and support to design validation including, but not limited to, use-related risk assessments.
• Support the generation of all regulatory submission data and content for assigned device projects.
• Support internal and external audits of the DCoE Quality Management System.
• Device development teams – device development leads, human factors SMEs, design engineers and device analytical scientists.
• Co-development team – drug product and device SMEs.
• Quality Assurance
• GCMC (Regulatory)
• PGS – manufacturing sites and post launch device team.
• External designers and contract manufacturing organizations.
EDUCATION, SKILLS AND EXPERIENCE
• BSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries
MSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries
• History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
• Experience in risk management for combination products and medical devices.
• Familiar with Human Factors Engineering – Usability Engineering.
• Familiar with device assembling manufacturing processes.
TECHNICAL SKILLS REQUIREMENTS
• Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
• Familiarity EN 62366, EN 60601, and EN 62304.
• Able to learn and apply established procedures in a reliable and consistent manner.
• Capable of working independently with minimal supervision.
• High level of attention to technical details and accuracy.
• Understand Good Manufacturing Practices (GMP).