Clinical Expert

hace 3 semanas


Madrid, Madrid, España Sgs A tiempo completo

Company Overview

We are SGS, a global leader in inspection, verification, testing, and certification. Our team of experts enables a better, safer, and more interconnected world.

 

Job Description

As Clinical Expert for Medical Device Certification, you will play a key role in the clinical evaluation assessment process. You will work closely with clinicians and specialized product reviewers to ensure compliance with EU MDR regulations.

 

Responsibilities

  • Act as primary clinical expertise within SGS Medical Device certification activities.
  • Review and scientifically challenge clinical data contained within the clinical evaluation and any associated clinical investigations.
  • Coordinate and guide external clinical experts in the clinical assessment and evaluate the results.
  • Draw records and reports regarding clinical assessment and make recommendations to the notified body's decision maker.
  • Develop, update, and maintain training packages (focusing on clinical evaluation assessments) for clinical experts and specialists.
  • Provide clinical input into client queries and meetings.

 

Qualifications

Essential:

  • A qualified physician.
  • University degree (Medical Doctor) plus further academic training in a clinically related research area or medical device field.
  • At least two years of experience in assessing clinical data for medical devices (closely related products like pharmaceuticals may also be considered).
  • Fluent English language skills (reading and writing).

 

Desirable:

  • Knowledge of medical device regulations MDR and related MDCG guidance.
  • Working experience in another notified body or experience in writing or assessing clinical evaluation reports.

 

Benefits

  • We offer a hybrid working environment.
  • Opportunity to work with a global leader in inspection, verification, testing, and certification.
  • Collaborative and inclusive work environment.
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.

 

Estimated Salary: $80,000 - $110,000 per annum



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