R&D Partners is seeking to hire a Clinical Evaluations Specialist Regulatory Documentation in Johns Creek, GA .
Your main responsibilities as a Clinical Evaluations Specialist Regulatory Documentation:
Author, revise, and update clinical documents for MDR remediation and PPRRs.
Conduct systematic literature reviews and clinical data appraisals in alignment with EU MDR, MEDDEV 2.7/1 Rev. 4, and FDA guidance.
Review and summarize large clinical documents such as literature reports, clinical research protocols, and templates.
Assist in the development and maintenance of Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) Plans and Reports, and risk-benefit analyses.
Support regulatory submissions by ensuring all clinical documentation meets scientific and regulatory standards.
What we are looking for in a Clinical Evaluations Specialist Regulatory Documentation:
Master s or Ph.D. in Vision Science, Biomedical Engineering, Life Sciences, or related field.
Foreign-trained ophthalmologists are encouraged to apply.
Proficiency in European Medical Device Regulations (MDR), particularly in clinical evaluations and post-market surveillance.
Experience in writing and reviewing clinical evaluation reports (CERs), literature reviews, and clinical risk assessments.
Strong background in regulatory compliance, medical writing, and scientific research methodologies.
Why Choose R&D Partners ?
As an employee, you have access to a comprehensive benefits package including:
Pay Scale:
$120,577 $150,724 ( Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.
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