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:
1. 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.
2. Support and facilitation of effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
3. Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
4. Provide input and support to design validation including, but not limited to, human factors engineering assessments.
5. Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
6. Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
7. Support the generation of all regulatory submission data and content for assigned device projects.
8. Support internal and external audits of the DCoE Quality Management System.
9. Identify, communicate, and develop strategies to improve combination product systems.
Basic Qualifications:
10. BSc, MSc or PhD 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
11. 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.
12. Experience in design controls for combination products.
13. Device risk management expertise.
14. Familiar with Human Factors Engineering - Usability Engineering.
15. Understand project management methodologies and capable to provide technical leadership for projects.
16. Familiar with device assembling manufacturing processes.
17. Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
18. Working knowledge of EN 62366, EN 60601, and EN 62304.
19. Able to learn and apply established procedures in a reliable and consistent manner.
20. Capable of working independently with minimal supervision.