Post-Market Vigilance Report Writer
Eastridge Workforce Solutions is committed to connecting skilled professionals with meaningful career opportunities. This is an opportunity to step into a highly visible post-market quality function supporting a global medical device organization focused on improving patient outcomes. This role will act as a key contributor to global complaint handling and vigilance reporting, ensuring regulatory compliance and supporting product safety initiatives across multiple regions.
Key Responsibilities:
• Assess, triage, and support follow-up activities for global product complaints
• Author, peer review, and approve vigilance reports to ensure timely submission to regulatory authorities
• Ensure accurate coding and classification of complaints and reportable events
• Collaborate with engineering, complaint investigation labs, medical, and cross-functional teams to evaluate events and support compliance
• Serve as a subject matter expert for post-market surveillance and complaint handling inquiries
• Contribute to non-conformances escalated into the CAPA system
• Support internal and external audits and inspections
• Assist with special projects and ongoing quality initiatives
Qualifications:
• Bachelor’s degree or equivalent combination of education and experience
• Demonstrated experience in medical device complaint triage and vigilance reporting OR clinical experience supporting diabetes disease management or device support
• Proven experience writing and submitting vigilance reports within a regulated environment
• Strong understanding of global regulatory requirements and post-market surveillance
• Experience working within a Quality Management System (QMS)
• Strong analytical, organizational, and communication skills
Preferred Qualifications:
• Direct experience writing and filing global vigilance reports within the medical device industry
• Experience with global, multi-country vigilance reporting requirements
• Experience interacting with regulatory authorities
• Clinical background such as BSN, Registered Dietitian, or Certified Diabetes Educator
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