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Product Quality Coordinator
3 weeks ago
We are currently collaborating with our client, a leading healthcare supplier and top-ranked medical device company.
This is a hybrid role, with 2 days in the office and the remainder remote. You will report to the Regulatory Affairs Manager.
Your core responsibilities include:
This role suits highly motivated professionals with exceptional attention to detail to ensure compliance with procedures, regulations, and guidelines.
- Support the Regulatory Affairs Manager in managing regulatory, compliance, pharmacovigilance & medicovigilance activities for products on the Irish market.
- Manage product complaints from initial receipt through to closure, in conjunction with the company's Global Complaints Departments.
- Document and maintain complaint files for reports received.
- Promptly communicate complaints to the Global Complaints Department and escalate serious issues as necessary.
- Liaise with customers regarding product quality issues and respond to medical/technical/clinical queries.
- Review complaint investigation reports and document correspondence / letters for customers.
- Assist in coordinating product recalls, field safety corrective actions, quality defect investigations, and compliance issues.
- Support Pharmacovigilance, Medicovigilance, Compliance, and Regulatory Affairs activities as directed.
- Provide training to personnel on handling product quality complaints, medicovigilance, and pharmacovigilance.
- Contribute to documenting and reviewing local procedures for product quality complaints, medicovigilance, and product recalls.
- Attend internal and external audits related to your job.
