Regulatory Affairs Administrator
hace 2 días
Manchester
Job title: Regulatory Affairs Administrator Reports to: Senior Regulatory Affairs Specialist Location: Onsite role based at our Manchester HQ located at Manchester Science Park, M15 6SH Contract Type: Full-time, Permanent Salary & Benefits: Competitive Salary + Benefits Package About Yourgene Health: Yourgene Health is a leading integrated technologies and services business, enabling the delivery of genomic medicine. The group works in partnership with global leaders in DNA technology to advance diagnostic science. Our mission to enable scientific advances to positively impact human health remains at the core of our focus. It drives and motivates us to develop class leading products and services to meet our customers’ needs. Yourgene primarily develops, manufactures, and commercialises simple and accurate molecular diagnostic solutions, for reproductive health, precision medicine and infectious diseases. We have a comprehensive offering of non-invasive prenatal tests (NIPT) NGS workflows that have been built with labs in mind, and clinical prenatal screening services. The IONA® test was the pioneer, the first to market as an IVD product, changing the NIPT screening landscape back in 2015. Continuing to build on our expertise in cell-free DNA, our next generation size selection Ranger® Technology uses machine vision for superior precision. With multiple platforms for a range of clinical and research cfDNA sample preparation applications including NIPT, liquid biopsy, gene synthesis and long fragment recovery. In addition, we offer a portfolio of screening products in reproductive health, precision medicine and infectious disease including screening assays for cystic fibrosis and DPYD genotyping to prevent chemotoxicity. Yourgene Genomic Services provides a range of genetic analysis services for our clinical, research and pharma customers to support partners with DNA extractions, biobanking, genotyping, arrays and sequencing workflows (WES and WGS). Yourgene Genomic Services offers a Non-Invasive Prenatal Testing (NIPT) Service, enabling clinics to run their own NIPT service for pregnant women with our prenatal screening tests and service laboratory based in Manchester. Yourgene Health is part of the Novacyt group of companies and is headquartered in Manchester, UK with facilities in Singapore and Canada. Our Culture: Yourgene is a growing, vibrant and exciting place to work, we are looking for committed driven individuals to be part of our next growth journey. Our culture is described by our employee's as collegiate, friendly, professional, innovative, open and fast paced. We have many social and wellbeing initiatives run by our Nova Social and Charity Huddle that keep our sense of community and togetherness alive. At Yourgene we focus on putting values led programmes in place to ensure that we can attract, retain and develop our people. We want our people to have a career with Yourgene and we ensure that they are recognised and rewarded for their achievements and commitment, everyone plays a critical role in our growth journey. Description of role: Yourgene Health, part of the Novacyt Group, are recruiting for a Regulatory Affairs Administrator at Yourgene Health is responsible for maintaining the Post Market Surveillance activities in compliance with the IVD Regulation (IVDR) and any other relevant global markets. This role will help to support the effective monitoring of the organisation’s in vitro diagnostic devices, allowing Yourgene Health to remain in compliance with the IVD Regulation by routinely reporting on the safety and effectiveness of devices currently on the market. Key areas of responsibility: • The maintenance of the Post Market Surveillance schedule in accordance with the requirements of the IVD Regulation (2017/746/EC), TG(MD)R 2002, CMDR SOR-98-282 and The Medical Devices (Post-Market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368)., • The completion of Post Market Surveillance activities on an annual basis and in accordance with the schedule, including:, • Conducting vigilance searches using keyword search terms or product codes of national/international incidents databases such as MHRA Medical Device Alerts and Field Safety Notices (UK), Database for Recalls, Product Alerts and Product Corrections (DRAC) (Australia), Health Canada Recalls and Safety Alerts, Swissmedic (Switzerland), FDA Medical Device Recalls and MAUDE Database (USA), FDA Medical Devices Recalls Database (USA), EUDAMED Vigilance Database and HSA Online Safety, Compliance Application and Registration (OSCAR) System (Singapore)., • Conducting literature searches using scientific databases such as PubMed and the Cochrane Library databases to identify scientific literature pertinent to the device and evaluate its performance in the market., • Collating the post market surveillance data inputs from all functions into a final report format to either present as a Post Market Surveillance Report, Periodic Safety Update Report or Post Market Performance Follow Up Report., • Analysing data to form an overall conclusion of the post market activities, whether any further actions are required, whether there are any findings of significance that may affect the risk of the device and/or whether the device continues to perform and is safe and effective in the market., • Maintain specialist personal knowledge of the regulatory requirements within the operational global markets and disseminate information of relevance within the Regulatory Affairs function., • Monitor the regulatory environment within the operational global markets, assessing the impact of any new of changing regulations to internal regulatory processes., • As required, participate in medical device reporting, product recalls and withdrawals., • Perform all duties in compliance with the Quality Management System, IVDR, ISO 13485, ISO 9001 and any other identified regulatory requirements., • As required, support any third party assessments. Qualifications, Skills and Abilities: • Degree in a life science subject or medical field (Molecular Biology, Genetics, Biotechnology, Biochemistry or similar)., • Minimum of 1-3 years of relevant experience with in-vitro diagnostic devices (preferred) or medical devices industry., • Experience of working within the Regulatory Affairs remit, knowledge of international regulations is highly desirable., • Knowledge of working to a QMS, ISO 13485, ISO 9001 and IVDR., • Excellent organisational and time management skills with an ability to work to tight timelines., • High level of attention to detail., • A positive attitude., • Demonstrate the ability to effectively collaborate and work as part of a team., • Proficient in the use of IT, including Microsoft Office suite., • Excellent communication skills when liaising within the company and with external customers. Closing Date: Sunday 16th November, 2025 Equal opportunities: Yourgene Health and the Novacyt Group of companies provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law. Notice to Agency and Search Firm Representatives: Yourgene Health and the Novacyt Group of companies is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Yourgene Health and Novacyt Group employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Yourgene Health and the Novacyt Group of companies. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
