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Medical Device Specialist - Manchester, United Kingdom - Yourgene Health
Description
Reports to :
Global Head of QA/RA
Manchester Science Park / Hybrid working arrangement
Contract Type :
Permanent / Full-Time
Salary & Benefits :
Competitive Salary + Benefits Package
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.
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.
We are looking to recruit a full-time and permanent Clinical Affairs Specialist on a hybrid working basis. 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 EvaluationThe 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.
product demand, target selection, sample type, competitor analysis) as well as regulatory requirements.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.
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.) 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.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.
Proficient in the use of IT, including Microsoft Office suite.
High level of molecular biology technical competence – PCR, qPCR, NGS
Sunday 19th May, 2024
Yourgene Health is committed to encouraging equality, diversity and inclusion among our workforce.
