We are collaborating with a leading global healthcare provider ranked in the Top 20 Medical Devices Companies. This company is seeking a Product Quality & Complaints Coordinator, a hybrid role that includes two days of work in Dublin and remote work for the remainder of the week. The position reports to the Regulatory Affairs Manager.
Key Responsibilities:
* Support the Regulatory Affairs Manager in managing regulatory, compliance, pharmacovigilance, and medicovigilance activities related to products sold in Ireland.
* Manage product complaints for products on the Irish market from initial receipt to closure in accordance with EU legislation, HPRA guidelines, and company-specific SOPs.
* Document and maintain complaint files for reports received.
* Communicate complaints promptly to the Global Complaints Department and escalate serious issues as necessary within required timeframes.
* Liaise with customers regarding quality issues and medical/technical/clinical queries in collaboration with Sales teams, ensuring accurate and prompt responses.
* Review product complaint investigation reports and document customer correspondence/letters within required timeframes.
* Assist in coordinating, implementing, and documenting product recalls, field safety corrective actions, quality defect investigations, compliance issues, vigilance issues, and mock recalls.
* Support Pharmacovigilance, Medicovigilance, Compliance, and Regulatory Affairs activities as directed.
* Provide training as required to relevant personnel on handling product quality complaints, medicovigilance, and pharmacovigilance.
* Contribute to documentation and review of local procedures relating to product quality complaints, medicovigilance, pharmacovigilance, and product recalls.
* Participate in internal and external audits related to this position.
Additional Tasks:
* Fulfill additional administration and quality support as required.
* Support other team members during annual or sick leave as needed.
Requirements:
* Bachelor's degree in a life science or pharmacy-related discipline.
* A minimum of three years' experience in a Medical Device/Pharmaceutical Industry with knowledge of GDP and product complaints handling for medical devices and/or medicinal products.
* Familiarity with relevant legislation, regulations, and guidelines applicable in Ireland and the EU.
* Proficiency in English; strong verbal and written communication skills are essential.
* Ability to process technical information.
* Accuracy and attention to detail are crucial, along with strong organizational skills.
* A proactive and collaborative work style and ability to manage multiple priorities and deadlines.
* Demonstrated interpersonal skills and ability to communicate with people at all levels within the organization and externally.
* Able to work independently and determine priorities to achieve results.
* Demonstrated problem-solving skills and ability to drive task completion.
* Proficiency in Microsoft Office and experience with SAP is an advantage.