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Medical Reviewer - Clinician SME - Remote

NextLink Solutions

Posted on Feb 8, 2021 by NextLink Solutions

Not Specified, Spain
Health Care
Immediate Start
Annual Salary
Full-Time


Medical Reviewer - Clinical SME - Remote


Initial 6 Month Contract - May lead to permanent role.


Overview


Position will be integral part of client organization group who are implementing European Medical Devices Regulation (MDR) for disposable and electromechanical devices. She/he will be responsible for reviewing, assessing, and updating the risk management documents and overall document sign-off.


Position Responsibilities:


  • Assess impact of new regulations and support implementation of appropriate changes in company policy and positions on draft regulation and guidance.

  • To review the gap assessments of Clinical Evaluation Reports to meet MEDDEV Rev 4/MDR compliance

  • Review the in progress Clinical Evaluation Reports

  • Review IFUs and product claims for specified client products and suggest changes.

  • Review scientific literature and clinical studies cited in CERs and assess whether there is sufficient clinical evidence.

  • Determine if indications and claims for products are supported by clinical data.

  • Review remediated CERs as needed prior to issuance.

  • Assist in developing clinical study protocol design and/or post market clinical follow up.

Essential Criteria


  • Medical Degree with super-specialty in specific therapeutic area/PhD with relevant experience/Biomedical engineering with relevant experience.

  • Total working experience: 10-12 Years

  • Medical writing experience for at least for 3-5 years




Reference: 1087779679

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