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Regulatory Compliance Expert
1 month ago
**Quality Engineer - 12 months contract - Hybrid - upto £24 per hour Umbrella**
**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 Management System.
**Requirements:**
- Bachelor's degree in an appropriate science or engineering discipline with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries OR Master's degree in an appropriate science or engineering discipline with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries OR Ph.D. in an appropriate science or engineering discipline.
- 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 design controls and risk management for combination products.
- Familiarity with Human Factors Engineering - Usability Engineering.
- Familiarity with device assembling manufacturing processes.
**Technical Skills:**
- Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Familiarity with EN 62366, EN 60601, and EN 62304.
- Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
- Able to work collaboratively in cross-functional teams.
- Excellent communication (e.g., oral, written, presentation) and interpersonal relationship skills.
- Proficiency in general computer software such as word processing, spreadsheets, presentations.
- Understanding of Good Manufacturing Practices (GMP).
