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IN-HOUSE CLINICIAN, GLOBAL MEDICAL DEVICES

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SGS

15d ago

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

AI generated summary

  • You need a relevant degree, 2+ years in clinical diagnostics, fluent English, and experience with IVD performance data. Knowledge of IVDR and device evaluations is a plus.
  • You will review clinical data for diagnostics, coordinate with external experts, prepare assessment reports, provide clinical input to clients, and develop training for team members.

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 in this position?

The In-house Clinician acts as a key member of the clinical team to ensure the safety and efficacy of in-vitro diagnostic medical devices, supporting the conformity assessment process in accordance with EU regulations.

What kind of experience is required for this role?

A minimum of two years of professional experience in the field of clinical diagnostics is required, ideally including roles such as physician, clinical pathologist, or clinical scientist.

Is knowledge of the EU IVDR required for this position?

While knowledge of the EU In-vitro Medical Device Regulation (IVDR) is desirable, it is not listed as an essential requirement for the role.

What educational qualifications are necessary for the In-house Clinician position?

Applicants must have a university degree in a relevant domain to qualify for the position.

Will the In-house Clinician need to work with external clinical experts?

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

What languages must candidates be fluent in?

Candidates must be fluent in English, both reading and writing.

How does the company support the professional development of its employees?

The In-house Clinician is responsible for developing, updating, and maintaining training packages for clinical experts and other team members.

Is there an expectation to engage with clients directly?

Yes, the In-house Clinician will offer appropriate clinical input into client queries and meetings.

What type of assessments will the In-house Clinician conduct?

The role involves reviewing and scientifically challenging clinical data contained within clinical performance evaluations and associated clinical investigations.

Are there any certifications or professional registrations preferred for this role?

Professional accreditation and/or active registration with relevant professional societies is highly advantageous and preferred for candidates.

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.