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Principal Quality & Regulatory Specialist

United Kingdom - Remote Horizon Req ID JR-039926
Scientists wearing lab coats

Revvity | About Us

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000+ colleagues from around the globe are vital to our success and the reason we’re able to push boundaries in pursuit of better human health.

Find your future at Revvity.

We are looking for a Principal 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.

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