Clinical Evaluations Specialist - Medical Device Regulatory Affairs

Job Summary

The Clinical Evaluations Specialist manages regulatory documentation for MDR remediation and PPRRs, requiring expertise in clinical literature reviews, regulatory writing, and post-market surveillance. This role supports medical device life cycle management and collaborates with cross-functional teams. Foreign-trained ophthalmologists are encouraged to apply.

This is a 6-month on-site contract in Duluth, GA, with the potential for extension.

location: Duluth, Georgia

job type: Contract

salary: $65.00 - 72.46 per hour

work hours: 9 to 5

education: Masters

Responsibilities

• Regulatory Documentation & Clinical Evaluation: Author, revise, and update clinical documents for MDR remediation and PPRRs, conduct systematic literature reviews, appraise clinical data, and develop Clinical Evaluation Reports (CERs), PMCF Plans and Reports, and risk-benefit analyses to support regulatory submissions.
• Life Cycle Management & Risk Assessment: Serve as the clinical contact for Life Cycle Management (LCM) and PPLCM activities, providing clinical expertise and ensuring compliance with global regulatory requirements.
• Process Improvement & Compliance: Monitor regulatory changes (EU MDR, FDA, ISO 14155), enhance SOPs for clinical evaluations, and track quality metrics to ensure ongoing compliance and process improvements.
  
  

Qualifications

Required:

• Master's in Vision Science, Ophthalmology, Biomedical Engineering, Biomedical Sciences or related degree.
• Experience with EU MDR, MEDDEV 2.7/1 Rev. 4, and FDA guidelines in the context of clinical evaluations and post-market surveillance
• Experience authoring or contributing to Clinical Evaluation Reports, Post-Market Clinical Follow-up Reports, or Risk-Benefit Analyses?
• Preferred:
• Foreign-trained ophthalmologists
• Experience in ophthalmology or eye care
• Experience conducting systematic literature reviews and appraised clinical data to support regulatory submissions RAC, AMWA, or EMWA certification(s)
  
  

skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, ICH Regulations

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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