Complaint Vigilance Specialist I

About the role

The Complaint Vigilance Specialist I ensures that all product complaints are captured, evaluated, and reported in compliance with global regulatory requirements. Working closely with pharmacovigilance, regulatory affairs, in‑country teams and device quality assurance, the specialist acts as the primary liaison for regulators and internal stakeholders.

Key responsibilities

• Make reportability decisions for product complaints.
• Lead vigilance reporting for both local and global submissions.
• Collaborate with pharmacovigilance, regulatory affairs, in‑country teams and device QA to prepare and submit reports.
• Provide visibility of reporting status to relevant stakeholders.
• Manage regular reporting obligations and external regulator requests (e.g., FDA).
• Oversee end‑to‑end reporting timelines.
• Coordinate translation services for reporting documentation.

Required profile

• Bachelor’s degree in life sciences, pharmacy, nursing or a related scientific field (preferred).
• 5+ years of experience in a cGMP‑regulated environment or clinical setting.
• Strong knowledge of global regulatory requirements for pharmaceuticals, medical devices and combination products.
• Familiarity with FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820, 211).
• Ability to prioritize multiple projects while ensuring regulatory compliance.
• Excellent written and verbal communication and strong organizational skills.
• Proficiency with computer systems for word processing and complaint management.
• Effective teamwork and stakeholder interaction skills.

Required skills

• Knowledge of global regulatory requirements for pharmaceuticals and medical devices.
• Understanding of FDA Quality Systems.
• Familiarity with Medical Device Reporting regulations (21 CFR 803, 820, 211).
• Experience with cGMP environments.

What we offer

• Comprehensive health and dental coverage.
• Extended vacation policy to support work‑life balance.
• Inclusive culture that promotes diversity and personal growth.