About the job
This hybrid role in Cebu City focuses on vigilance reporting for medical devices, with an immediate start date. During the probationary period, work will be on-site, transitioning to a hybrid setup afterward. The position supports voice-based operations and follows an 8 PM to 5 AM shift, Monday through Friday, with weekends off.
Role overview
The Vigilance Reporting Associate prepares and submits Medical Device Reports (MDRs), manages product safety documentation, and ensures compliance with industry regulations. This role also generates monthly vigilance reports for the EMEA region, processes Individual Case Safety Reports (ICSRs), and handles case triage for drug safety activities. Managing customer complaints and assessing MDR reportability are core aspects of the position.
Requirements
- Bachelor’s degree in Nursing, Biology, Microbiology, Electromedical Engineering (Biomedical Engineering), Industrial or Mechanical Engineering, or a related science or technology field
- Minimum of 2 years drafting vigilance reports for medical devices in a shared services, BPO, or call center setting
- Strong written English communication skills
- Good understanding of ISO 13485 and USA Medical Device Regulations
Key responsibilities
- Prepare and submit MDRs, review product safety literature, and maintain complaint documentation to meet compliance standards
- Generate monthly vigilance reports for EMEA region safety monitoring
- Process ICSRs and handle case triage for drug safety
- Manage customer complaints and assess MDR reportability, ensuring compliance with applicable standards
Work arrangement
- Hybrid setup (on-site during probationary period)
- Location: Cebu City, Cebu, Philippines
- Voice support
- 8 PM – 5 AM shift, Monday to Friday (weekends off)
- Immediate start date
