The following opportunity is for a multinational pharma & biotech company based in Cambridgeshire. They have been around for over 100 years and have an outstanding record for astonishing breakthroughs. The role would offer you the chance to work with combination products in a multi functional role and a lot of flexibility to work from home.

Responsibilities

• Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
• Support risk management activities at external design companies and manufacturing facilities related to assigned projects.
• Ensure combination product development activities are compliant with quality and regulatory standards
• Support design validation human factors engineering assessments
• Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply
• Support device design and manufacturing investigations from devices used in clinical trials
• Creation of technical documentation
• Support internal/external audits
• Combination product development strategy

Qualifications

• BSc in scientific field with roughly 5 years' experience with combination products/medical devices
• Familiar with Human Factors Engineering & design controls
• Project management experience
• Experience with IEC62366, IEC60601, IEC62304, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, EU MDR

If you want to be part of an innovative, growing company GET IN TOUCH - Please email me your CV at louise.cleland@biotalent.com and we can arrange confidential chat.