Senior Regulatory Specialist

Job Description

Company ProfileYourgene 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 UsAt 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 DescriptionDescription of role: Regulatory Affairs professional with knowledge of In Vitro Diagnostics industry.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 a level of management and liaison with internal team functions, regulatory authorities, and Yourgene Health’s partner organisations. Minimum qualifications are a degree in Life Sciences, either in genetics or molecular biology and significant experience working within a regulatory affairs arena. Key areas of responsibility:The creation, management and maintenance of Technical 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.Involvement with the IVDR planning transition for the business.Experience of country registration processes for world wide commercial support.Prepare regulatory dossiers to support product license applications, import license and product license maintenance for worldwide Regulatory Authorities.Proactively manage relationships and communications with regulatory agencies and authorised representatives.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 companies 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.Develop transitional plans, as required, to ensure the business continues to operate to current and future regulatory requirements. Support product risk management activities and the life-cycle of marketed products.Support for the post market surveillance, 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 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 (e.g. potential suppliers, Competent Authorities, Regulatory Bodies).Qualifications, Skills and Abilities:Degree in a life science or equivalent either in genetics or molecular biology and significant experience working within a regulatory affairs arena.Knowledge of ISO 13485 and IVD Directive requirements. Awareness / training of the IVD Regulations.Excellent organisational skills and an ability to work to tight timelines.Demonstrate strong team skills.Proficient in the use of IT, including Microsoft Office suite.Excellent communication skills when liaising within the company and with external customers.ValuesTeamworkTrustIntegrityCommitmentAchievementRecognitionBehaviours Constructive challengeNo phones/Laptops in meetingBe on timeProvide feedbackBe preparedBe honestBe engagedOne conversationBe sharpBe committedBe awareBenefits:Private Health Care5 x Death in ServiceDiscretionary Bonus (in 2019 this was £1000 per employee)25 Days Holiday plus 8 Bank Holidays which increases by one day each years up to a maximum of three years1 Additional Days holiday for your birthday, to be taken in the week of your celebration