Overview
Job Title: Design Control and Risk Management Compliance Engineer. Contract: 12 months. Hours:37 hrs p/w. Location: Cambridge. Pay rate: up to £20.79 p/h DOE.
Responsibilities
* Lead design control and risk management activities for medical device combination product development programmes, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
* Support and facilitation of effective design control and risk management activities internally, at external design companies, and at the business manufacturing facilities/CMOs related to assigned projects.
* Generation, approval, and retention of business' design control and risk management documentation ensuring that quality and regulatory requirements are satisfied.
* Ensure medical device combination product design control and 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 medical device combination product projects.
* Support internal and external audits of the Biotherapeutics Pharmaceutical Research and Development Quality Management Systems.
Organizational Relationships
* Device development teams - Drug Product leads, packaging engineers, medical device combination product engineers, 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.
Qualifications
* 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 OR
* 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 design control for medical device combination products and/or medical devices
* Experience in risk management for medical device combination products and/or 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.
* 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.
* Understand Good Manufacturing Practices (GMP).
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