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IN-HOUSE CLINICIAN, GLOBAL MEDICAL DEVICES

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SGS

14d ago

  • Job
    Full-time
    Junior Level
  • Consulting
    Healthcare
  • Dublin
  • Quick Apply

AI generated summary

  • You need a relevant degree, 2+ years in clinical diagnostics, fluency in English, and experience in IVD or performance data interpretation; knowledge of IVDR is a plus.
  • You will review clinical data, coordinate external expert involvement, create assessment reports, develop training packages, and provide clinical input for client interactions.

Requirements

  • Essential:
  • Professional experience in the field of clinical diagnostics. This may include experience as a physician, clinical pathologist, clinical scientist, clinical biochemist, biomedical scientist, clinical diagnostics laboratory manager, etc. Professional accreditation and/or active registration with relevant professional societies is highly advantageous
  • University degree in a relevant domain
  • At least two years of experience relevant to the generation and/or interpretation of performance data for in-vitro diagnostic assays in a clinical setting
  • Fluent in English, reading and writing
  • Desirable:
  • Knowledge of the EU in-vitro medical device regulation (IVDR) and related MDCG guidance
  • Working experience in the IVD industry and knowledge of device clinical performance evaluation, such as verification and validation studies, clinical studies
  • Experience with clinical investigations of in-vitro diagnostic assays or biomarker discovery studies
  • A keen interest in medical device regulatory affairs

Responsibilities

  • Act as the primary clinical expertise within SGS In-vitro Diagnostic Medical Device certification activities
  • Review and scientifically challenge the clinical data contained within the clinical performance evaluation, and any associated clinical investigations
  • Coordinate the involvement of external clinical experts in the assessment process – deciding when external expertise is required, guiding the experts in their tasks and evaluating the results
  • Draw up records and reports regarding clinical assessment, and make recommendation to the notified body’s decision makers
  • Develop, update and maintain appropriate training packages (with a focus of clinical evaluation assessments) for clinical experts and other team members
  • Offer appropriate clinical input into client queries and meetings

FAQs

What is the primary role of the In-house Clinician?

The primary role of the In-house Clinician is to act as a key member of the clinical team within a Notified Body, ensuring the safety and efficacy of in-vitro diagnostic medical devices in Europe.

What qualifications are essential for the In-house Clinician position?

Essential qualifications include professional experience in clinical diagnostics, a university degree in a relevant domain, at least two years of experience related to the generation and/or interpretation of performance data for IVD assays, and fluency in English.

Is knowledge of EU regulations required for this position?

While it is not strictly required, knowledge of the EU in-vitro medical device regulation (IVDR) and related MDCG guidance is highly desirable for the role.

How many years of experience are required for this job?

At least two years of relevant experience in the generation and/or interpretation of performance data for in-vitro diagnostic assays in a clinical setting is required.

Are there opportunities for collaboration with external experts in this role?

Yes, the In-house Clinician will coordinate the involvement of external clinical experts in the assessment process, guiding them in their tasks and evaluating the results.

Is a medical degree necessary to apply for this position?

A medical degree is not explicitly required, but professional experience in clinical diagnostics fields such as physician, clinical pathologist, or clinical biochemist is essential.

What types of clinical input are expected from the In-house Clinician?

The In-house Clinician is expected to offer appropriate clinical input into client queries and meetings, as well as review and scientifically challenge clinical data.

Will the In-house Clinician be involved in training development?

Yes, the In-house Clinician will be responsible for developing, updating, and maintaining training packages focused on clinical evaluation assessments for clinical experts and team members.

Is experience in the IVD industry beneficial for this role?

Yes, working experience in the IVD industry and knowledge of clinical performance evaluation is highly desirable for this position.

What type of organization is SGS?

SGS is the world's leading testing, inspection, and certification company, recognized as a global benchmark for sustainability, quality, and integrity.

SGS

When you need to be sure

Consulting
Industry
10,001+
Employees

Mission & Purpose

We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 98,000 employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world. Community Guidelines Welcome to our LinkedIn page! SGS encourages all fans of this page to participate in the conversation through questions and comments. Any comments or activity arising from persons sharing or otherwise reproducing any communications published by SGS is not controlled or endorsed by SGS.