RA Manager

Company Profile Yourgene Health is an international molecular diagnostics group which develops and commercialises genetic products and services. The group works in partnership with global leaders in DNA technology to advance diagnostic science. Our product development, research service and commercial capabilities extend across the lifecycle of DNA test development including regulatory submissions. Yourgene Health’s first commercialised products are non-invasive prenatal tests (NIPT) for Down’s syndrome and other genetic disorders, targeting a share of an emerging billion-dollar global market. Our commercial footprint is already established in the UK, Europe, the Middle East, Africa and Asia. Through our technical expertise and partnerships, Yourgene Health is aiming to extend its genetic testing offering into complementary areas of reproductive health and oncology. Why Join Us? At Yourgene Health we pride ourselves in our culture and performance of our people. We live by our values and behaviours. We set annual global business goals which cascade down to departmental goals and individual employee goals to support the performance of not just the business but our employees who contribute towards our success. We are a global business with locations in Manchester, Taipei, India, Singapore and most recently the US. Job Description Job Title: RA Manager Reports to: QA & Regulations Director Description of role: Regulatory Affairs (RA) professional with expert knowledge within the in vitro Diagnostics industry and of managing/leading RA teams. Overall responsibility: This role 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 management and liaison with the senior management team, internal team functions, regulatory authorities, and Yourgene Health’s partner organisations. Key areas of responsibility: • Managing a small RA team covering all areas of regulatory support for the business • Lead the creation, management and maintenance of Technical Files / Medical Device Files for the Yourgene Health product range in accordance with the requirements of the IVDD 98/79/EC and MDD Directive 93/42/EC, including CE-marking activities. • Manage and lead the IVDR planning transition for the business. • Experience of country approval (e.g. FDA, TGA, HC and ANVISA) and registration processes for worldwide commercial support • Lead and support the preparation of regulatory dossiers to support product license applications, import license applications and maintenance of the same for worldwide Regulatory Authorities. • Proactively manage relationships and communications with regulatory agencies and authorised representatives. • Maintain a high level of specialist knowledge of the regulatory requirements within each of operational geographical territories. • Manage the collation, interpretation and dissemination of specialised regulatory information across the business. • Generate the development of the company’s regulatory plan, incorporating strategies for the product range in accordance with global requirements. • Actively monitor the regulatory environment, assessing the impact of new or changing regulations to the business. • Develop and coordinate transitional plans, as required, to ensure the business continues to operate to current and future regulatory requirements. • Provide regulatory direction and support for the product risk management activities and the lifecycle of marketed products. • Provide regulatory direction and support for post market surveillance, preparing reports for the product range, annually. • Oversee the issuance of regulatory compliant product labelling and Instructions For Use documentation, liaising with other departments, including the provision of translations from translation service providers. • Lead and participate in medical device reporting, product recall and withdrawals events, liaising with internal management, regulatory authorities, and partner organisations, as appropriate. • Lead the regulatory requirements of the product development process, contributing to product validation plans, reports, claim support papers and other post market activities. • Conduct all duties in compliance with GMP, ISO13485, ISO9001, GCP and other regulatory requirements, as identified. • Support third party assessments. Consults with: • Yourgene Health management and staff (e.g. Development team, Clinical team, QA). • Other Yourgene Health functions (e.g. Legal, Finance, HR, Admin). • External companies and authorities (e.g. potential suppliers, Competent Authorities, Regulatory Bodies). Supervisory/Management Responsibilities: • Small Team Qualifications, Skills and Abilities • A degree in Life Sciences, either in genetics or molecular biology. • Significant experience of working within the MDD and/or IVDD regulatory affairs arena. • Evidenced experience of successfully managing/leading an RA team. • Knowledge of ISO 13485 and IVD Directive requirements. • Knowledge/application/training of the IVD Regulations. • Knowledge/application of EU harmonised standards associated with ivds • Excellent organisational skills and an ability to work to tight timelines. • Demonstrates excellent/strong team skills. • Very proficient in the use of IT tools and systems, including Microsoft Office suite, EDMS software. • Excellent communication skills when liaising within the company and with external companies and authorities. Benefits: • Private Health Care of BUPA Cash Plan • 5 x Death in Service • Discretionary Bonus • 25 Days Holiday plus 8 Bank Holidays which increases by one day each years up to a maximum of three years • 1 Additional Days holiday for your birthday, to be taken in the week of your celebration As an employee’s time in service and accountability increases, as do the benefits. Should this be applicable this would be discussed at interview.