Quality Assurance and Regulatory Affairs Specialist

Origin Sciences is a start-up biotechnology company based in Granta Park, just south of Cambridge. We develop our own innovative medical devices, which we use in clinical trials to collect a biobank of mucus-based biospecimens. This biobank provides clinical material for our research and development streams to assist with diagnostic development.

Our primary disease area is Colorectal Cancer (CRC).  We are creating a minimally invasive and accurate CRC diagnostic, which will allow the NHS to focus resources on patients with more serious pathologies. Our motivations are to reduce NHS waiting times, enable earlier CRC detection and reduce unnecessary investigations performed on healthy patients.

Our CRC diagnostic is analogous to blood-based liquid biopsies. However, we have the advantage of evaluating material that was collected closer to the pathology of interest.

Responsibilities:

• QMS Development & Maintenance: Contribute to the development, implementation, and maintenance of the Quality Management System (QMS), ensuring compliance with ISO 13485 and other relevant standards.
• Regulatory Support:Provide regulatory support in the preparation and writing of technical documentation and for UKCA and CE marking medical devices, ensuring alignment with the regulation.
• QMS System Implementation:Support the implementation and maintenance of Origin Sciences' electronic QMS (Greenlight Guru), ensuring that regulatory requirements are seamlessly integrated.
• SOP Development:Prepare, review, and implement ISO 13485 compliant Standard Operating Procedures (SOPs) for functions across the business, with a focus on regulatory and quality aspects.
• Non-Conformance & CAPA:Contribute to the investigation and analysis of non-conforming products and processes, supporting Corrective and Preventive Action (CAPA) activities and ensuring regulatory compliance throughout the process.
• Audit Support:Act as an internal auditor for quality systems, products, and processes, ensuring ongoing compliance with ISO 13485 and other relevant regulatory standards.
• Supplier Quality:Assess critical suppliers’ ongoing suitability, maintaining and developing supplier quality agreements, and ensuring compliance with regulatory standards.
• Customer Complaints:Contribute to the development and maintenance of the customer complaints procedure, ensuring that regulatory reporting requirements are met.
• Regulatory Documentation:Support the Head of Regulatory Affairs with clinical study documentation, risk management, and reports for regulatory submissions, ensuring compliance with the necessary regulatory frameworks.
• QMS Management Review:Contribute to QMS Management Review meetings, including preparation of reports regarding the quality system, performance relative to quality objectives, and overall QMS effectiveness.
• External Communication:Serve as the liaison with external parties on matters related to the quality management system, including quality audits conducted by regulatory bodies or notified bodies.

Requirements

• Regulatory Knowledge:Strong understanding of the European Medical Device Regulation (MDR) and UK MDR for medical devices.

• QMS Experience:Hands-on experience with developing and maintaining a Quality Management System (QMS) compliant with ISO 13485, and experience with electronic QMS systems like Greenlight Guru is a plus.
• Risk Management:Knowledge of risk management processes, including familiarity with ISO 14971 for medical devices.
• Audit Experience:Experience with internal auditing of quality systems and products, and familiarity with regulatory audits (e.g., BSI ISO 13485 audits).
• Problem-Solving Skills:Ability to contribute to the investigation and resolution of non-conformances, CAPA activities, and customer complaints in compliance with regulatory requirements.
• Collaboration Skills:Strong communication skills, with the ability to work effectively with cross-functional teams and external regulatory bodies.
• Degree:A degree in a relevant scientific field, such as molecular biology, biomedical engineering, or a related discipline.
• Fluent in English: Strong verbal and written communication skills in English.
• Attention to Detail:Excellent organisational and attention-to-detail skills, especially when working with technical documentation and regulatory compliance processes.
• Independent & Adaptable:Ability to work autonomously and handle regulatory challenges in a dynamic, fast-paced environment.

Benefits

• 25 days of holiday
• Pension contribution
• Hybrid working option