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IN-HOUSE CLINICIAN, GLOBAL MEDICAL DEVICES

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SGS

12d ago

  • Job
    Full-time
    Junior Level
  • Science
    Healthcare
  • Amsterdam
  • Quick Apply

AI generated summary

  • You need clinical diagnostics experience, a relevant degree, two years in IVD performance data, and fluent English. Knowledge of IVDR and regulatory affairs is a plus.
  • You will review clinical data, coordinate external experts, prepare assessment reports, develop training packages, and provide clinical input for client queries and meetings.

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 role of the In-house Clinician at SGS?

The In-house Clinician is a key member of the clinical team responsible for ensuring the safety and efficacy of in-vitro diagnostic medical devices available in Europe. They provide clinical expertise, review clinical data, and support adherence to the EU In-vitro Diagnostic Medical Devices Regulation (IVDR).

What qualifications are essential for this position?

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

Is professional accreditation required for this role?

While professional accreditation and/or active registration with relevant professional societies is highly advantageous, it is not explicitly stated as a requirement.

What additional knowledge is desirable for candidates?

Desirable knowledge includes understanding the EU IVDR and related MDCG guidance, experience in the IVD industry, familiarity with clinical performance evaluation, and an interest in medical device regulatory affairs.

Will the In-house Clinician work independently or as part of a team?

The In-house Clinician will work as part of a team, collaborating with clinicians and specialized product reviewers during the conformity assessment process of IVD devices.

What specific responsibilities are associated with the role?

Responsibilities include acting as the primary clinical expertise during certification activities, reviewing clinical data, coordinating external clinical experts, documenting clinical assessments, developing training packages, and providing clinical input for client queries.

Is prior experience in the IVD industry required?

While prior experience in the IVD industry is not mandatory, it is considered highly desirable, especially experience with device clinical performance evaluation and clinical studies.

What kind of working environment can a candidate expect?

Candidates can expect a professional working environment focused on the assessment of clinical aspects of in-vitro diagnostic medical devices, with collaboration among clinical experts and technology specialists.

How many years of experience are required for this job?

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

Is fluency in any other languages required?

Fluency in English, both reading and writing, is required, but proficiency in other languages may be an asset depending on the client base.

SGS

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10,001+
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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.