Job Title - Device Compliance Engineer

Location - Cambridge

Contract - 12 months

Working pattern - Hybrid

Pay - PAYE - £16.77 p/h up to £25.98 p/h, Umbrella - £18.79 p/h up to £29.12 p/h

SRG are working with a global leading pharmaceutical company that are seeking a Device Compliance Engineer to join their busy team.

Key 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 and facilitation of effective 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, both internal and external. Provide input and support to design validation including, but not limited to, 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 and commercial manufacture. Support the generation of all regulatory submission data and content for assigned device projects. Support internal and external audits of the DCoE Quality Managem...