Internal Clinician - Ecorse, MI, United States - Matrix Dynamics

Matrix Dynamics
Matrix Dynamics
Verified Company
Ecorse, MI, United States

3 weeks ago

James Miller

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James Miller

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Freelance
Description

Local Unit & Position Description:


DNV MEDCERT is a certified organization based in Ecorse, MI that specializes in ISO 13485 certification, MDSAP auditing, and Medical Devices Regulation compliance.

Our mission is to ensure global market access for products and systems by certifying their safety and quality according to international standards and regulations.

We pride ourselves on maintaining high professional standards and promoting sustainability in our work. As an organization that values its employees, we are committed to providing opportunities for continued development.

We are currently seeking an Internal Clinician to join our DNV MEDCERT Clinical Affairs Team in Hamburg.

In this role, you will be responsible for overseeing the clinical evaluation assessment of technical documentation and participating in the conformity assessment and decision-making process.


Key tasks include:

  • Working within the company's quality management system
  • Ensuring regulatory compliance of the clinical evaluation assessment process and improving its performance and interaction with other processes
  • Reviewing and scientifically challenging the clinical data in the evaluation and guiding clinical experts in their assessment
  • Scientifically evaluating and potentially challenging the clinical evaluation and the results of the clinical experts' assessment
  • Ensuring consistency in the assessments of clinical evaluations conducted by clinical experts
  • Documenting and reporting on your involvement in relevant conformity assessment activities
  • Providing guidance to product reviewers and clinical experts on aspects of the manufacturer's design or production processes that may impact the clinical evaluation
  • Training internal and external personnel on clinical requirements
  • Identifying and acquiring external clinical experts as needed
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