Regional Quality Assurance Associate

Responsibilities

Quality Assurance

• Provide oversight of Quality Assurance programs, systems, processes, and procedures to ensure compliance with regulatory requirements, company policies, and applicable standards (global, regional, and local).
• Support internal and external audits and regulatory inspections; coordinate with global teams (e.g. US) to execute corrective and preventive action plans related to field issues.
• Support Supply Chain operations by working with third-party logistics providers and internal warehouses to ensure proper product handling and stewardship. Including value added services (labelling) implementation.
• Collaborate cross-functionally to support new market entries and product launches in the region.
• Deliver quality and regulatory training to internal and external stakeholders as required.

Post-Market Surveillance (PMS)

• Coordinate the receipt, investigation, evaluation, and regulatory reporting of medical device incidents.
• Identify and communicate potential process risks and recommend mitigation actions, collaborate with internal functions and external partners as required
• Maintain effective quality processes to ensure consistency, accuracy, and reliability in surveillance activities; continuously assess and improve vigilance processes, methodologies, and tools to enhance effectiveness and efficiency.
• Support PMS projects, including global process improvements and digital enablement of data collection.
• Promote patient safety through transparent communication, sound decision-making, and appropriate risk management.

Regulatory Support

• Maintain awareness of applicable regional and international medical device regulations.
• Liaise with Regional Regulatory Affairs, local regulatory authorities, distributors, and external consultants.
• Support product registrations, renewals, and variations as needed.