Design Control and Risk Management Compliance Engineer

Job Title: Design Control and Risk Management Compliance EngineerContract: 12 monthsHours:37 hrs p/wLocation: CambridgePay rate: up to 20.79 p/h DOE Role overview This position is in the Biotherapeutics Pharmaceutical Research and Development (Drug Product Design and Development) located in Cambridge, UK. The incumbent will provide design control and risk management subject matter expertise to medical device combination product development programmes throughout the product lifecycle. This will involve ensuring consistent implementation of applicable processes and standards across the portfolio, in addition to the facilitation and documentation of specific design control and risk management activities, whilst interacting with cross functional development teams at all levels of the organisation. Primary Duties: 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 ..... full job details .....