Regulatory Affairs Manager
About the job
- A degree in Biomedical Science, Molecular Biology, Genetics, Life Sciences or a related scientific discipline is required.
- Significant Regulatory Affairs experience within the medical device and/or in vitro diagnostic industry is required.
- Strong working knowledge of the EU In Vitro Diagnostic Regulation (IVDR (EU) 2017/746) and Medical Device Regulation (EU MDR 2017/745) is required.
- Demonstrable experience developing and maintaining Technical Documentation for medical devices and/or in vitro diagnostic devices is required.
- Experience supporting the regulatory development of novel in vitro diagnostic technologies, including genomic, molecular and software-based diagnostics, is required.
- Experience with Software as an In Vitro Diagnostic and an understanding of software lifecycle and validation requirements, including IEC 62304, is required.
- Strong understanding of design control, product lifecycle management and regulatory change management is required.
- Hands-on experience with risk management in accordance with ISO 14971 is required.
- Experience preparing or contributing to Clinical Evaluation Reports, Performance Evaluation Reports, Biological Evaluation Reports and Post-Market Surveillance documentation is required.
- Experience supporting regulatory submissions and interactions with Notified Bodies and Competent Authorities is required.
- Working knowledge of ISO 13485 and associated regulatory standards is required.
- Excellent written and verbal communication skills in English are required.
- The candidate must be highly organised, pragmatic and able to manage multiple regulatory projects within a fast-paced development environment.
- Lead Regulatory Affairs activities for medical devices, in vitro diagnostic medical devices, including software as an in vitro diagnostic and genomic diagnostic technologies.
- Develop, maintain and update Technical Documentation in accordance with EU MDR, IVDR and other applicable regulatory requirements.
- Support the development and implementation of regulatory strategies for new product development, product changes and lifecycle management.
- Prepare and maintain regulatory documentation including Technical Files, Risk Management Files, Clinical Evaluation Reports, Performance Evaluation Reports, Biological Evaluation Reports and associated technical documentation.
- Provide regulatory input throughout the product development lifecycle, ensuring compliance with design control, verification, validation and change management processes.
- Lead regulatory activities relating to analytical performance, clinical performance, scientific validity and software validation.
- Support Post-Market Surveillance, vigilance, trend reporting and regulatory compliance activities.
- Conduct regulatory impact assessments and provide guidance on product, manufacturing and quality system changes.
- Work collaboratively with R&D, Software, Bioinformatics, Clinical and Quality teams to integrate regulatory requirements into product development.
- Support regulatory submissions, Notified Body interactions and market access activities within the EU, UK and other international markets.
- Provide regulatory training and technical guidance to internal teams and support the Person Responsible for Regulatory Compliance where required.
- Monitor changes to relevant regulations, standards and guidance and assess their impact on the business and products.
- Experience with Class C in vitro diagnostic devices under IVDR.
- Experience supporting AI-enabled or bioinformatics-driven diagnostic technologies.
- Experience with analytical performance, clinical performance and scientific validity studies.
- Experience with UKCA, FDA or other international regulatory frameworks.
- Previous experience acting as, or supporting, the Person Responsible for Regulatory Compliance.
About the company
Origin Sciences develops diagnostic tools for colorectal cancer using a unique rectal mucosa sample collected with the Oricol device. The core product is the Oricol diagnostic platform, which gathers high-quality rectal mucosa samples that are analyzed to produce accurate cancer diagnostics. The Oricol CRC PreView test, currently in development, aims to more precisely determine whether a patient has colorectal cancer. The company sells its diagnostic devices and tests to healthcare providers, hospitals, and clinics, targeting a non-invasive, affordable, and efficient screening option. Unlike some competitors, Origin Sciences emphasizes using a specific mucosal biospecimen and an integrated device-and-test approach to deliver convenient, cost-effective diagnostics. The overall goal is to improve early detection and diagnosis of colorectal cancer by providing accurate, accessible tools for clinicians and patients.
Company Size
11-50
Company Stage
N/A
Total Funding
N/A
Headquarters
Cambridge, United Kingdom
Founded
2004
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Simplify's Take
What believers are saying
- CE marking in August 2026 clears a major commercialization hurdle in Europe.
- Primerdesign and Illumina collaborations broaden validation and distribution pathways in 2026.
- Growing colorectal-cancer demand favors earlier, less invasive diagnostics like OriCol.
What critics are saying
- The SEC filing shows substantial going-concern doubt and only $8.3 million cash by June 2026.
- Origin Sciences still needs clinical adoption; CE marking never guarantees reimbursement or sales.
- If fundraising fails before 2027, TOGL faces shutdown, asset sales, or severe dilution.
What makes TOGL (Holdings) unique
- OriCol targets rectal mucus, a biospecimen rivals ignore for CRC screening.
- TOGL and Origin Sciences won CE marking for OriCol in August 2026.
- Primerdesign partnership in March 2026 strengthens DNA extraction workflow around proprietary samples.
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Benefits
Paid Holidays
Flexible Work Hours
Company News
Shropshire hospital trust shortlisted for Trust of the Year. 10th August Shrewsbury Hospital. An NHS trust has been shortlisted for Trust of the Year and two other national awards recognising outstanding performance in healthcare. The Shrewsbury and Telford Hospital NHS Trust (SaTH) is a finalist in three categories at the 2026 Health Service Journal (HSJ) Awards, including Trust of the Year, Performance Recovery, and Modernising Diagnostics. SaTH runs Princess Royal Hospital and the Community Diagnostic Centre (CDC) in Telford and Royal Shrewsbury Hospital and is part of the Shropshire, Telford and Wrekin Community and Hospitals NHS Group. Jo Williams, group chief executive of the Trust, said: "I am proud that its teams are receiving this phenomenal recognition. "Border Counties Advertizer do not underestimate the improvement that Border Counties Advertizer still have to deliver, but Border Counties Advertizer is pleased to be among the most improved trusts nationally. "This progress, and now this recognition, is built on countless acts of kindness, hard work, resilience, compassion, and an unwavering commitment by our incredible staff to do the very best for others." The Trust of the Year Award recognises NHS organisations that have made significant improvements in reducing waiting times, enhancing clinical quality, and maintaining financial resilience while prioritising staff wellbeing and inclusivity. SaTH has made notable progress in elective care, outpatient services, and cancer care, and successfully delivered its financial plan, allowing it to exit special measures after seven years. The Performance Recovery Award highlights rapid and effective improvements for patients, staff, and the wider community. SaTH was recognised as the most improved trust nationally in 2025/26 for 18-week referral to treatment (RTT) waiting times and the 28-day Faster Diagnosis Standard for cancer. The Modernising Diagnostics Award celebrates innovation in diagnostic services, including redesigned pathways and improved collaboration. SaTH, working alongside Origin Sciences, has been recognised for the TRIOMIC cancer trial, which has redesigned the Colorectal Urgent Suspected Cancer pathway to be delivered in a Community Diagnostic Centre (CDC), whilst also developing a new test to detect colorectal cancer and high-risk polyps. The £2 million study, the first of its kind in the UK, also developed a new test for detecting colorectal cancer and high-risk polyps. Dr John Jones, group medical director, said: "To be shortlisted for three awards is testament to the determination of its staff to deliver high quality, safe and effective patient care and Border Counties Advertizer would like to thank them for everything they do. "We remain ambitious for better care, safer services and a kinder culture and we will continue to challenge ourselves to further improve, to keep listening to our patients and staff, and to strive for the standards our communities rightly expect from us." Winners will be announced at the HSJ Awards ceremony on Thursday 19 November 2026. More Stories
Primerdesign partners with Origin Sciences to create novel rectal mucosal extraction workflow. March 23, 2026 Manchester, UK, and Cambridge, UK, 24 March 2026: Primerdesign (part of the Novacyt Group), a company focused on the design, manufacture, validation and supply of nucleic acid extraction and real-time PCR kits, and Origin Sciences (Origin), a company pioneering the detection and diagnosis of gastrointestinal (GI) disease through an unprecedented focus on a unique biospecimen: rectal mucus; today announced a strategic partnership to create a new protocol that optimises DNA extraction from novel rectal mucosal samples. The custom workflow will help to unlock molecular insights from these challenging sample types and improve diagnostic utility in gut health conditions. Origin's patented, extensively tested medical device, OriCol(TM) enables reliable, rapid, minimally invasive sample collection of rectal mucus, addressing the urgent need for accurate, affordable in vitro diagnostics for colorectal cancers and advanced adenomas. The capabilities and performance of these testing applications is determined by the quality and efficiency of material recovery from the biospecimen. Primerdesign offers capabilities in custom assay development and high-quality nucleic acid extraction solutions as part of its exsig(R) Mag range. Together, they have collaborated to develop an innovative, robust and reproducible sample collection and nucleic acid extraction workflow that demonstrates consistent performance and high DNA yields from rectal mucus samples. Sampling methodologies have previously limited the investigation of gut health and diseases, which often rely on stool or blood. Rectal mucus contains the cells and molecular signals shed from the lining of the entire colon. This provides a diverse and consistent biospecimen for representative gut examination that is uniquely suited for detecting the earliest signs of GI disease as well as residual disease monitoring, treatment selection and recurrence surveillance. Dr Jo Mason, CSO of Novacyt, said: "By unlocking the diagnostic potential of rectal mucus, Origin is helping to transform early detection, disease management, and patient outcomes worldwide. The performance of these testing applications hinges on the efficacy of the genetic material recovery. Our team is proud to have an outstanding reputation in custom assay development and nucleic acid extraction. Working in collaboration with Origin has resulted in a highly efficient custom DNA extraction workflow that will help to expedite the screening and diagnosis of colorectal cancer and other GI diseases." Dr Daniel Wise, CSO of Origin Sciences, added: "Bio-IT World Inc is pleased to partner with Primerdesign's expertise in high-quality custom DNA extraction from rectal mucus samples to deliver a scalable, bespoke nucleic acid extraction system that outperforms all commercially available alternatives assessed. Extracting high-quality DNA data from its samples will allow Bio-IT World Inc to detect GI diseases at its earlier stages so Bio-IT World Inc can save lives, save time, and save money." Download the whitepaper 'A Novel Extraction Methodology for a Novel Biospecimen' to learn more about the novel rectal mucosal extraction workflow: https://www.primerdesign.co.uk/learn/your-expert/.
SaTH has collaborated with industry for the trial, with Origin Sciences providing funding for staff and capital costs to support the development of the new pathway.