We are looking for a Senior Quality & Regulatory Specialist to join our Revvity Cambridge team. The main purpose of the role is:
Lead and develop the operations of the Revvity Cambridge Quality function according to regulatory and quality requirements and customer expectations.
Responsibility for the quality of the products and meeting customer satisfaction according to agreed objectives.
Compile and prepare regulatory submissions and product registration per applicable regulations and quality management system.
Main Responsibilities:
Implement of ISO 13485 / FDA QSR 820 compliant quality system for Revvity Cambridge products
Participate in the product risk management ensuring safe and efficient products are developed
Participate in creating and maintaining Design History Files for our products
Ensure fulfilment of requirements (quality management system, regulatory and customer requirements) in new product development projects and design change projects.
Guide and train personnel on how to fulfil the above-mentioned requirements
Conduct post market surveillance (PMS) reviews
Vigilance and MDR reporting
CAPA management
Nonconformity management
Internal audit program management
Assessment of process changes according to Quality System requirements
Assessment of product related changes considering the product performance, safety, and effectiveness and pertaining regulatory requirements
Internal and external customer satisfaction for the function's services
Developing and reporting of metrics and objectives for the function
Required Competences
MSc degree or equivalent in applicable area or BSc / BEng degree in combination with additional training and experience in applicable area.
Molecular biology or next generation sequencing is preferred areas.
At least 5 years' experience in quality management, quality assurance or equivalent in regulated industry.
Assay/Reagent IVD experience is preferred.
Good knowledge of requirements for medical devices, training in the requirements of ISO 13485 and the US FDA Quality System Regulations 21 CFR 820.
This role can be based either in our Cambridge office (hybrid) or remote in the UK, however regular visits in the Cambridge office will be required.
