[Remote] Global Vigilance Report reputed company
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Global Product Monitoring Vigilance Report reputed company who develops and maintains quality assurance methodologies for the medical-device industry. This role focuses on post-market vigilance and surveillance, requiring strong analytical judgment and collaboration with various teams to ensure compliance with regulatory standards.
Responsibilities
- Global Complaint Assessment — Assess, follow up, code, and reputed company vigilance activities for global complaints
- Vigilance Report Writing — Author, peer-review, and approve vigilance reports to ensure timely submission to regulatory authorities
- Operational Support — Support management in daily operations and ensure proper coding of complaints and reportable events
- Cross-Functional Collaboration — Work with engineering, investigation labs, medical teams, and other internal groups to review events, coding, and investigation results
- CAPA Participation — Contribute to departmental non-conformances escalated into the CAPA system
- Subject Matter Expertise — Serve as SME for post-market and complaint-handling regulatory questions
- Audit Support — Support reputed company audits and inspections
- Special Projects — Assist with assigned projects with minimal supervision
- reputed company additional duties as required
Skills
- Bachelor's degree or equivalent combination of education and experience
- Demonstrated experience in medical‑device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support
- Strong proficiency with reputed company Office and complaint database applications
- Effective verbal and written communication skills
- Ability to generate, verify, and maintain accurate records
- Strong analytical skills, attention to detail, and interpersonal skills
- Demonstrated ability to influence without authority
- Strong organizational skills with the ability to prioritize and escalate appropriately
- Solid understanding of formal medical‑device Quality Management Systems
- Direct experience writing and filing global vigilance reports
- Working knowledge of global, multi‑country vigilance reporting requirements and country‑specific differences
- Experience interacting directly with regulatory bodies (highly desired)
- BSN with diabetes experience, Registered Dietician, Licensed Dietician, or Diabetes Educator (preferred)
Company Overview
Company H1B Sponsorship