We are currently recruiting for a Product Quality & Complaints Coordinator. This is a hybrid role with 2 days a week onsite and 3 days remote. This is for a maternity leave contract cover. Require a motivated, detail-oriented and customer-focused individual to join the Regulatory Affairs team to coordinate product quality complaint handling and support related regulatory compliance activities for products placed on the Irish market. Role reports to the Regulatory Affairs Manager Role & Responsibilities: *Support the Regulatory Affairs Manager in the effective coordination of product quality, vigilance and regulatory compliance activities for products placed on the Irish market *Manage product quality complaints from initial receipt through to closure, in conjunction with the companys Global Complaints functions, in accordance with applicable EU/Irish requirements, HPRA guidance and internal procedures. *Create, maintain and control complete complaint files and records (including supporting evidence, communications and decision rationale) in line with internal requirements and audit readiness expectations. *Ensure prompt logging and communication of complaints to Global Complaints, including timely escalation of potential serious incidents/priority complaints to appropriate local and global stakeholders within required timeframes. *Act as a point of contact for customers and internal teams (e.g., Sales/Customer Service) on product quality queries, ensuring accurate information is gathered and responses are provided promptly and professionally. *Review investigation outputs and draft customer correspondence (where applicable) to communicate investigation findings and outcomes within agreed timelines. *Support the coordination, implementation and documentation of Field Safety Corrective Actions (FSCAs), product recalls, quality defect investigations and mock recalls, including liaison with Global Safety/Vigilance functions and the HPRA as required. *Provide support to Pharmacovigilance/Medicovigilance, compliance and regulatory activities as directed, including the triage of adverse event/incident information and onward reporting via the appropriate channels. *Deliver or coordinate periodic training and awareness activities (as required) for relevant personnel on complaint handling, vigilance awareness and recall/FSCA processes. *Contribute to the preparation, review and continuous improvement of local procedures and work instructions relating to complaint handling, vigilance and product safety actions. *Participate in internal and external audits/inspections as required and support the timely completion of any assigned actions. Skills & Experience Requirements: *A third-level qualification in a life science, biomedical, pharmacy or related discipline (or equivalent relevant experience). *Minimum 23 years experience in a regulated Medical Device and/or Pharmaceutical environment, ideally with exposure to complaint handling, quality systems or vigilance activities. *Working knowledge of relevant legislation/regulations/guidance applicable in Ireland and the EU (e.g., medical device vigilance expectations and HPRA guidance); familiarity with GDP/QMS principles is an advantage. *Excellent English communication skills (written and verbal) with the ability to produce clear, compliant documentation and communicate effectively with customers and internal stakeholders. *Ability to interpret technical information and apply it to complaint assessments, investigation follow-up and customer responses. *High accuracy and attention to detail, with strong planning, organisation and follow-through to manage multiple priorities and deadlines. *Proactive and collaborative approach, comfortable working with cross-functional/global teams and balancing competing demands. *Strong interpersonal skills with the ability to engage professionally with stakeholders at all levels, including external parties (e.g., customers and competent authorities) when required. *Ability to work both independently and as part of a team, exercising sound judgement and escalating appropriately. *Demonstrated problem-solving skills with a focus on timely completion, quality of output and continuous improvement. *Strong Microsoft Office skills; experience with SAP and/or quality/complaints databases is an advantage. For a full Job Spec and to apply for this role please call Linda on or e-mail Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: #LI-LD1 Skills: quality assurance complaints QA