Job Description

Job title : Clinical Evaluations Specialist – Regulatory Documentation

Location: Johns Creek, GA (onsite)

Duration : 6 months (possible extension)

Job Description :

The Clinical Evaluations Specialist is responsible for managing regulatory documentation related to clinical evaluations, particularly for Medical Device Regulation (MDR) remediation and Post Production Risk Reviews (PPRRs). This role requires strong expertise in clinical literature reviews, regulatory writing, and post-market surveillance activities to support the life cycle management of medical devices. The specialist will serve as a primary point of contact for clinical project leads and collaborate closely with cross-functional teams, including Regulatory Affairs, Quality Assurance, and Clinical Development.

Key Responsibilities:

Regulatory Documentation & Clinical Evaluation:

• 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.

Life Cycle Management & Risk Assessment:

• Act as clinical contact for Life Cycle Management (LCM) and Post Production Life Cycle Management (PPLCM) activities.
• Provide clinical functional review and expertise on assigned projects, ensuring compliance with global regulatory requirements.

Process Improvement & Compliance:

• Monitor evolving EU MDR, FDA, and ISO 14155 regulations to ensure compliance with clinical evaluation processes.
• Develop and improve standard operating procedures (SOPs) related to clinical regulatory documentation.
• Track and analyze quality metrics related to clinical evaluations and risk reviews.

Required Qualifications:

• 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.
• Proficient in Microsoft Office Suite and regulatory documentation software.
• Strong communication and writing skills.

Preferred Qualifications:

• Experience in eye care/ophthalmology is highly preferred.
• Experience in conducting systematic literature reviews and regulatory risk analysis.
• Knowledge of clinical trial registries, biostatistics, and regulatory intelligence.
• Certification in Regulatory Affairs (RAC), Medical Writing (AMWA, EMWA), or a related field.

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