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In House Clinician - IVD Medical Devices

Central London   •  Negotiable  •  Permanent, Full time


How can I assist you in finding your next Scientific role?

Working for CPL Life Sciences I developed my expertise around the Scientific Industry within the UK/EU market. I am helping Scientists & Professionals to become the future of our society by finding them the right career pathway that highlights their full potential.

Job Title: In House Clinician IVD Medical Devices

Location: Remote based roles (UK, France, Spain, Germany, Netherlands, Italy)

Working Hours/Flexibility: Full time or two part-times (every week availability is required)

Salary: Salary + Benefits (based on Location)

** Please read **

The following requirements are essential for this position:

Full right to work in the UK/EU

HCPC Registration as a Clinical Scientist or Biomedical Scientist or equivalent Registration for other EU countries such as France, Spain, Germany, Netherlands, Italy.

In Vitro Diagnostic experience Areas: Cancer, Infectious Diseases, Human Genetic Testing, Blood Grouping/Typing

Experience with High-risk IVDs, Class D/C

OUR CLIENT:

Cpl Life Sciences is collaborating with a global service organisation that provides a wide range of products and services in the Industry. Their purpose is to inspire the globe with innovative and sustainable solutions and services to improve the performance of organisations of all sizes effectively, from small businesses to multinationals.

WHY THIS IS A GREAT PLACE TO WORK:

Our Clients goal is to create a supportive and well inclusive and diverse culture where every individual is encouraged and motivated to fulfil and perform at their full potential. They value and prioritise the health and wellbeing of their employees by supporting global mental health awareness to enable every individual not to be afraid to reach out for help when needed. Additionally, they offer flexibility and room to grow professionally, offering career development by providing a variety of opportunities to support their people to make a positive difference to the world.

THE POSITION:

They are seeking an experienced Biomedical or Clinical Scientist to provide oversight to In Vitro device performance evaluation reviews conducted as part of the conformity assessment process. Additionally, the successful candidate will be required to provide an evaluation of the appropriate IVD device clinical/performance evaluation claims, insights of risk-benefit and residual risks and post-market performance follow up.

PRINCIPAL DUTIES AND RESPONSIBILITIES

Clinical guidance of the evaluation assessments.

Performance and data requirements evaluation.

Internal and external training in areas of expertise.

Regulatory development of IVD medical devices in the EU.

Support provider to the commercial team when required.

Liaison with technical reviewers and manufacturers ensuring that any concerns have been addressed.

BPG development and ensuring consistency of reviews for all performance evaluation assessments.

Technical staff and external experts mentoring, to ensure consistency in performance evaluation reviews for IVD devices.

ESSENTIAL CRITERIA:

Qualified clinical laboratory scientist (eg Biomedical/ Clinical/Healthcare Scientist) with senior management experience within a clinical laboratory setting or have a medical/scientific degree in a related discipline with significant experience in IVD device testing/performance evaluation

Experience working with IVDs in areas:

oPathology/Oncology, Biochemistry, Infectious diseases, Genetics, Blood grouping or Tissue Typing

Skills in IVD technologies such as flow cytometry, agglutination, immunoassays, molecular biology, biochemistry, physical chemistry or chromosomal analysis.

Analytical skills in IVDs data management.

If you are looking for an opportunity to enhance your experience, broaden your career horizons and change the future apply today.

Georgia.Mouzouridou@cpl.com

  • Agency: Cpl Life Sciences
  • Contact: Georgia Mouzouridou
  • Reference: JO-2201-483371
  • Posted: 12th January 2022
  • Expires: 9th February 2022

Cpl Life Sciences

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