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Senior Regulatory Affairs Specialist
2 months ago
Job title: Senior Regulatory Affairs Specialist
Reports to: Global Head of QA/RA
Location: Manchester Science Park
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.
Yourgene primarily develops, manufactures, and commercialises simple and accurate molecular diagnostic solutions, for reproductive health, precision medicine and infectious diseases. The Group's flagship in vitro diagnostic products include non -invasive prenatal tests (NIPT) for Down's Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests and DPYD genotyping.
Yourgene has a range of innovative DNA sample preparation platforms, powered by Ranger® Technology, the Yourgene LightBench® and Yourgene QS250, ideal for cell free DNA applications in NIPT and oncology including liquid biopsy.
Yourgene also has a global laboratory service network equipped to be a full life-cycle partner for clinical, research and pharmaceutical organisations to support partners at the preclinical, clinical, and post market stage to develop, manufacture, obtain regulatory approval and commercialise new products and services. In addition, Yourgene offers and NIPT and high throughput Covid testing service.
Yourgene Health is headquartered in Manchester, UK with facilities in Taipei, Singapore, the US 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 nay social and well-being initiatives run by our Social Huddle that keep our sense of community alive during challenging times that the pandemic has thrown our way. 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 Novacyt Group are recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist at Yourgene Health is responsible for the preparation and submission of regulatory documents in compliance to the IVD Regulation (IVDR) and any global regulatory compliance and supporting Post Market Surveillance activities.
Overall responsibility:
The Senior Regulatory Affairs Specialist will help support effective management of the organisation’s regulatory affairs strategy, in order to support and fulfil the company’s global commercial strategy. The role requires a level of liaison with internal team functions, regulatory authorities, and Yourgene Health’s partner organisations.
Key areas of responsibility:
- The creation, management and maintenance of Technical Documentation/Technical Files for the Yourgene Health product range in accordance with the requirements of the IVD regulation (2017/746/EC), including CE-marking activities.
- Knowledge of country registration including MDSAP requirements covering Australia, Canada, Brazil, USA and Japan country specific and other relevant global regulatory requirements processes for worldwide commercial support.
- Prepare regulatory dossiers to support product license applications, import license and product license maintenance for worldwide Regulatory Authorities.
- Maintain specialist personal knowledge of the regulatory requirements within each of operational geographical territories.
- Collate, interpret and disseminate specialised regulatory information across the business.
- Support for the development of the company’s regulatory plan, incorporating strategies for the product range in accordance with global requirements.
- Monitor the regulatory environment, assessing the impact of new or changing regulations to the business.
- Support product risk management activities and the life-cycle of marketed products.
- Support the post market surveillance activities, preparing reports for the product range, annually.
- Oversee the issuance of product instructions for use documentation, including the provision of translations, liaising with other departments to do so.
- As required, participate in medical device reporting, product recall and withdrawals events, liaising with internal management, regulatory authorities, and partner organisations.
- Support the regulatory requirements of the product development process, contributing to product verification and validation plans, reports, and other post market activities.
- Conduct all duties in compliance with IVDR, ISO13485, ISO9001, and other regulatory requirements as identified.
- Support 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 3-5 years of relevant experience with in-vitro diagnostic devices (preferred) or medical devices industry.
- Significant experience working within a regulatory affairs arena – International including FDA, Australia and Canada desirable.
- Strong Knowledge of ISO 13485 and the IVDR requirements.
- Excellent organisational skills and an ability to work to tight timelines.
- High level of attention to detail.
- Demonstrate strong team and time management skills.
- 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 21st July, 2024
Yourgene Health is committed to encouraging equality, diversity and inclusion among our workforce. The aim is for our workforce to be truly representative of all sections of society and for each employee to feel respected and able to give their best.
