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Bioinformatics Compliance Specialist

Bioinformatics Compliance Specialist

CT19

We are looking for Bioinformatics Compliance Specialist to join a Next Generation Sequencing (NGS) Biotechnology company based in London. If you are looking to join a growing company at the forefront of cutting-edge genomic diagnostics technology that are on a mission to improve patient diagnostics and care then read on.
 
The successful candidate will be working on the compliance of BioInformatics pipelines and processes to the following standards: ISO13845, IEC62304, IEC 62366 standards
 
Bioinformatics Compliance Specialist
Location: White City London (Flexible WFH)
Salary: £DOE + Benefits (25 days holiday, 4% Pension, Private Medical, Numerous soft benefits)
 
Responsibilities

  • Actively contribute to the Documentation of the bioinformatics pipeline component of  targeted sequencing solution as well as documentation of procedures and process configurations.
  • Guarantee compliance of Bioinformatics processes to Quality standards.
  • Train Internal users to Bioinformatics SOPs, from using autonomously the BioInformatics pipeline to data management (From Medical data to Sequence databanks).
  • Actively promote interactions within the Bioinformatics team by setting-up compliance reviews.
  • Participate in relevant regulatory forums to help ensure our product designs reflect the Bioinformatics challenges of a regulated diagnostic sample-to-answer sequencing tests.
  • Partners with the IT, Regulatory and Software teams to document, test and validate new analytical tools and processes.
  • Ensures compliance with all relevant standards to guarantee security, and confidentiality of transactions.
  • Actively support IT team to reach highest standards in cybersecurity of BioInformatics data (both in the final diagnostic platform and the environment)

 
Desirable Background:  

  • Confident in windows and Linux environments, Git source code repository, Jenkins
  • Clear communication skills and proven ability to train others.
  • Demonstrated ability to work autonomously and remotely (online work with daily stand-up meetings and frequent online interactions within the BioInformatics as well as several others teams such as IT, regulatory and Software). Experience:
  • Demonstrated experience (5+ years) in producing BioInformatics/software documents for regulated environments (ISO13845, IEC62304, IEC 62366 standards, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for industry and FDA Staff, and requirements, etc.).
  • Experience of the process requirements, documentation and traceability needed for regulated development. (Preferably, but not necessarily IEC 62304) (e.g. safety critical)
  • Experience developing medical software validation procedures. Desirable Experience
  • Ideally have worked within a multidisciplinary team with an emphasis on excellent communication skills.
  • Experience designing, developing, and validating medical device BioInformatics software (Nucleic Acids Amplification Technologies and/or Next Generation Sequencing)
  • Experience in software development flows for medical devices, and familiarity with relevant ISO standards such as 14971, 62304, 61010
  • Experience with scientific Python libraries – SciPy, NumPy, Pyplot, Pandas
  • Experience as internal auditor in clinical development context especially on topics linked to bioinformatics.
  • Knowledge of statistical and machine learning methods is a plus.

 
Please apply with an up-to-date CV for consideration.

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Job Overview
Category
Science & Biotechnology
Offered Salary
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Job Location