Clinical Affairs Specialist Regulatory Affairs · Manchester (Yourgene) · Hybrid Remote

Full Job Description

Regulatory Affairs · Manchester (Yourgene) · Hybrid Remote

Job title: Clinical Affairs Specialist

Reports to : Global Head of QA/RA

Location : Manchester Science Park / Hybrid working arrangement

Contract Type : Permanent / Full-Time

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. Yourgene work 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 and precision medicine. Yourgene'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 Size Selection instruments, powered by Ranger Technology, ideal for cell-free DNA applications in NIPT, oncology including liquid biopsy, long fragment recovery and gene synthesis applications.

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 an NIPT testing service in the Manchester laboratory.

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 plenty of social and well-being initiatives run by our Nova Social & Charity Huddle that keep our sense of community alive and allow us to be part of charity fundraisers. 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.

About the role:

We are looking to recruit a full-time and permanent Clinical Affairs Specialist on a hybrid working basis. The Clinical Affairs Specialist will be supporting continuing clinical evidence and clinical benefit for the Yourgene and Novacyt Group clinical portfolio of IVD assays/instruments. The majority of responsibilities include Clinical Performance Studies and Performance Evaluation, with the aim of improving the company’s processes surrounding Clinical Evidence and Performance Evaluation

The individual will ensure sufficient clinical evidence and clinical benefit is achieved for IVD assays and instruments in addition to reviewing/generating new clinical evidence post market where needed in relation to the performance evaluation process.

This individual will be responsible for coordinating and completing Performance Evaluation Plans and Performance Evaluation Reports. Including the gathering of Scientific Validity and State of the Art evidence to support the performance evaluation of IVDR assays. The individual will also be responsible for Post Market activities such as writing and conducting the Post Market Performance Follow Up (PMPF) Plan and Reports, as well as contributing to Post Market Surveillance as a Clinical SME.

The individual will support Marketing where needed and participate in device development from the start, with the insight they will have in market needs (e.g., product demand, target selection, sample type, competitor analysis) as well as regulatory requirements.

Key areas of responsibility:

• Completion and management of Performance Evaluation Plans, Reports, and Processes.
• Gathering of evidence to show Scientific Validity and State of the Art for IVDR submissions.
• Management of Post Market activities including PMPF plans and reports, sit as a clinical SME during post market activities.
• Collaborate with the clinical research team to support clinical performance studies for Novacyt’s in-vitro diagnostic medical devices, ensuring compliance with the ISO 20916:2019 standard and IVDR requirements.
• Ensure documentation (protocols, reports, risk assessments, consent forms etc.) is up to date and in compliance with standards and regulations.
• Familiarity with the market needs to support device development. This may involve networking with hospitals and laboratories to investigate which type of products and which pathogens are the most in demand, what sample type is used, and which competitors are on the market.
• Work with RA to ensure the clinical performance study is compliant for the target markets.
• Supporting marketing, to build and strengthen the network of laboratories, hospitals, and Key Opinion Leaders to support planning and execution of state-of-the-art clinical performance studies. Work closely with QA/RA in ensuring that projects are run to relevant quality standards (both internal and external standards) for medical devices and in-vitro diagnostic equipment.
• Assist the marketing team with any feasibility/workflow projects that might be performed in a post-market follow up study.
• Ensure continuing clinical evidence and benefit post market through further studies, literature review or EQA studies

Qualifications, Skills and Abilities

• Degree in molecular biology/biomedical sciences or science related discipline.
• Minimum of 3 years of relevant experience with in-vitro diagnostic devices (preferred) or medical devices industry.
• Knowledge of ISO13485, ISO 20916:2019 and IVD Regulation (2017/746/EC).
• Candidates must have excellent organisational and interpersonal skills.
• Ability to think in a logical manner, with excellent attention to detail.
• Excellent written communication and collaborative skills.
• Ability to multitask and work in a very fast paced, dynamic environment. Able to problem solve and deal with agreed timelines.
• Self-motivated.
• Proficient in the use of IT, including Microsoft Office suite.
• Previous experience in development of molecular diagnostics
• High level of molecular biology technical competence – PCR, qPCR, NGS
• Understanding of Precision Medicine, Reproductive Health, and/or infectious disease diagnostic markets.

Closing Date:

Sunday 19th May, 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.

Based on performance against both Corporate and Personal objectives

5% company contribution

25 days holiday (plus public holidays) with the option toBuy/Sell days each year

Giving you the peace of mind for your family should the worst happen

Includes optical and dental cover

At Novacyt , we believe in contributing to communities where we operate, and we have made donations to various charities and schools in the areas our offices are located.

Following the transformational financial performance of Novacyt in 2020, a charity steering committee was created made up from a number of key employees within the group tasked with identifying schools and charities in need of support particularly following the COVID-19 pandemic.

In 2021 a sum of £500,000 was dedicated to supporting a total of 25 schools and 50 charities throughout the year. We assisted projects looking to support critically ill children and adults, the homeless, old age pensioners and war veterans.

At Novacyt Group , we pride ourselves on concentrating our expertise on specific market needs. Offering a comprehensive and developing portfolio of quality products, backed by proven supply and delivery services, to ensure the highest possible standards of customer service around the world. Our passion is for customer-centric solutions that advance the science behind diagnostics. This fuels our drive to deliver products that save lives and help in the fight against infectious disease.

We offer an increasing portfolio of in-vitro diagnostic tests, utilising molecular and protein detection technologies – supporting healthcare and disease prevention across the globe in the clinical and life science sectors. Deep strengths in product development, commercialisation, contract design, and manufacturing ensure quality products and robust supply.

Our Group has specialist experience and expertise throughout our business units: Primer Design, Novacyt UK, IT-IS International, and Yourgene Health UK – creating solutions for the diagnostics industry, supplying an extensive range of high-quality assays and reagents worldwide.

Founded in 2005

Regulatory Affairs · Manchester (Yourgene) · Hybrid Remote

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