Regulatory Documentation Specialist (Medical Device) Job #48661

Astrix • Duluth, GA

292d • $58 - $72

About The Position

Join our amazing team! We want to help you continue to succeed and grow in the life sciences industry! Our Regulatory Documentation Specialist position is a great opportunity to work with a leading Pharmaceutical and Medical Device company! This is your chance to work closely with a company dedicated to enhancing quality of life by helping people see better.

Requirements

• Experience in writing and reviewing clinical evaluation reports (CERs), literature reviews, and clinical risk assessments
• Proficiency in European Medical Device Regulations (MDR)
• M.S. or Ph.D. in Biomedical Engineering, Life Sciences, Vision sciences, or related

Responsibilities

• Review, revise, and update clinical documents including literature reports, clinical research protocols, etc. for Medical Device Regulation (MDR) remediation and Postproduction Risk Reviews (PPRRs)
• Support regulatory submissions, ensure compliance with global regulatory requirements, and develop and improve SOPs relating to clinical regulatory documentation
• Responsible for clinical data appraisals, development and maintenance of Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF), and act as clinical contact for assigned projects and Life Cycle Management
• Monitor evolving EU MDR, FDA, and ISO 14155 regulations to ensure compliance with clinical evaluation processes

Benefits

• Medical/dental coverage
• Weekly pay
• 401k and PTO after 6 months

What This Job Offers

• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Master's degree