Vigilance Reporting Associate (Medical Device) | BPO | Cebu City
The HIRD Cebu Full-time
We are looking for a Vigilance Reporting Associate to support our Medical Device account. In this role, you will be responsible for preparing and managing vigilance reports, ensuring compliance with global regulatory standards.
Key Responsibilities- Prepare and submit vigilance reports for medical devices
- Ensure compliance with ISO 13485 and U.S. Medical Device Regulations
- Document and analyze adverse events and product complaints
- Maintain accurate and complete report documentation
- Coordinate with internal stakeholders for data collection and validation
- Ensure quality, accuracy, and timeliness of all reports
- Bachelor’s degree in Nursing, Biology/Microbiology, Biomedical Engineering, Industrial/Mechanical Engineering, or any related field
- At least 2–3 years of experience in medical device vigilance reporting
- Strong knowledge of ISO 13485 and U.S. Medical Device Regulations
- Excellent written English communication skills
- Detail-oriented with strong analytical skills
- Competitive salary package
- Night shift differential
- Hybrid work setup
- Weekends off
- HMO and health insurance
- Paid leaves (VL/SL)
- Government-mandated benefits (SSS, PhilHealth, Pag-IBIG)
- Career growth and development opportunities
- Supportive and collaborative work environment
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